Bjo_2016 569.576Ear acupuncture or local anaesthetics as pain reliefduring postpartum surgical repair: a randomisedcontrolled trial S Kindberg,a,c L Klu¨nder,b J Strøm,a TB Henriksenc a Department of Research and Medical Education and b Department of Obstetrics and Gynaecology, Sønderborg Hospital, Denmarkc Perinatal Epidemiology Research Unit, Department of Obstetrics and Gynaecology, Aarhus University Hospital, Skejby, DenmarkCorrespondence: S Kindberg, Perinatal Epidemiology Research Unit, Aarhus University Hospital, Skejby, 8200 Aarhus North, Denmark.
Email email@example.com Accepted 6 October 2008. Published Online 19 December 2008.
Objective To evaluate two methods of pain relief during 24–48 hours and 14 days postpartum, participant satisfaction, postpartum surgical repair in regard to effectiveness, wound revision of wound or dyspareunia reported 6 months postpartum.
healing and patient evaluation.
Results Pain during surgical repair was more frequently reported Design A randomised controlled trial testing a pragmatic set-up of by participants allocated to ear acupuncture compared with brief training of clinicians.
participants receiving local anaesthetics (89 versus 54%, P < 0.01).
Pain intensity during surgical repair was also reported higher Setting Delivery ward at a Danish district hospital with (Visual Analogue Scale score 3.5 versus 1.5, P < 0.01). The ear approximately 1600 annual deliveries.
acupuncture group received more additional pain relief during Population Primiparous women with a vaginal delivery at term repair (53 versus 19%, P < 0.01). No difference was observed in who needed surgical repair of lacerations to the labia or the vagina, wound healing at 24–48 hours or 14 days postpartum. Revision of perineal lacerations of first or second degree or mediolateral wounds was rare, and no difference occurred in this trial.
Comparable proportions of participants reported dyspareuniaat 6 months. Patient satisfaction with the allocated pain-relief Methods The trial was set up to evaluate the effect of a brief method was lower in the ear acupuncture group (69 versus 91%, 2-hour hands-on training in the use of ear acupuncture. All P < 0.01) and fewer women would recommend the method to midwives (n = 36) in the department had previous experience in a friend (74 versus 91%, P < 0.01).
using acupuncture for obstetric pain relief. Pain and woundhealing were evaluated using validated scores. Data collection was Conclusions Ear acupuncture as used in this trial was less effective performed by research assistants blinded towards treatment for pain relief compared with a local anaesthetic. No difference was allocation. Randomisation was computer assisted. A total of 207 observed in wound healing, need for revision of wound or women were randomised to receive ear acupuncture (105) and dyspareunia. Patient satisfaction with allocated pain-relief method local anaesthetics (102), respectively.
was lower in the ear acupuncture group.
Main outcome measures The primary outcome was pain during Keywords Acupuncture, local anaesthetics, midwives, pain relief, surgical repair. Secondary outcomes were wound healing at postpartum surgical repair.
Please cite this paper as: Kindberg S, Klu¨nder L, Strøm J, Henriksen T. Ear acupuncture or local anaesthetics as pain relief during postpartum surgical repair:a randomised controlled trial. BJOG 2009;116:569–576.
ations involving the anal sphincter or the rectal mucosa areclassified as third and fourth degree tears; these lacerations are Genital tract trauma is a frequent complication to vaginal repaired by doctors.2 delivery, and more than 80% of primiparous women sustain Women can experience pain and discomfort related to injury to the labia, vagina or perineum.1 Midwives usually sutures for weeks and even months after delivery. Several, perform the repair of labia tears, vaginal lacerations, perineal large randomised trials have shown that the continuous lacerations of first or second degree and episiotomies. Lacer- suturing technique with subcutaneous stitches placed well ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology Kindberg et al.
below the perineal skin surface is superior to interrupted The standard suture material in the department was a stitches in all layers, including stitches through the perineal rapidly absorbed multifilament suture with a 3/8 atraumatic skin.3–5 Pain and discomfort can also be reduced using a rap- needle (Vicryl Rapide gauge 2-0 or 3-0, Ethicon GMBH, idly absorbed synthetic suture material instead of products Norderstedt, Germany). The suture technique recommended with longer absorption time.4,6,7 in local guidelines was a continuous suture for vaginal There is scanty evidence on effective pain-relieving mucosa and perineal repair based on recommendations in a methods during perineal repair.8 A recent trial on different recent Cochrane Review.16 Labia tears were sutured according suture techniques reported that 50% of the participants expe- to the preference of the midwife.
rienced pain during perineal repair.9 A clinical observation Women requiring surgical repair of lacerations in the vulva from the use of local anaesthetics is that the injection of the area or perineal lacerations of first or second degree or medio- anaesthetic itself causes pain and may induce oedema of the lateral episiotomies were randomly allocated to receive either tissue.10 Therefore, there is a need to improve the quality and of the two pain-relief methods. Additional pain relief could be effectiveness of pain-relief methods for the repair of perineal supplied at any time during the surgical repair upon request and vaginal injuries following childbirth.
from patients. Application of 5-ml gel with 4% Lidocaine was In recent years acupuncture has been used for several first choice for both treatment groups.
obstetric indicaions.11 Randomised trials have also evaluatedthe effect of acupuncture on pain during labour.12,13 Ear acu- puncture provided by intensively trained midwives and obste- The acupuncture treatment consisted of six acupuncture tricians and specifically for postpartum perineal pain relief has been proposed. However, the effectiveness in clinical prac- Two 15-mm needles were placed on top of the helix of the tice has not been evaluated systematically.14 A randomised ear covering the ‘genital' area according to French Auriculo- controlled clinical trial was therefore conducted to compare therapy.17 The Shen Men point in the ear was used to increase the effect of ear acupuncture with local anaesthetics during the anaesthetic effect according to both French and Chinese surgical repair after vaginal delivery. The trial tested a brief traditions.15,17 Supplementary acupuncture was used: Bilater- training package in order to perform a clinically relevant eval- ally, a 40-mm needle was placed in the ‘Bladder 36' point uation of a focused introduction to a new pain-relief method.
located at the tuber isciadicus. One 15-mm needle was usedfor general relaxation in the ‘Governor Vessel 20' pointlocated on top of the head according to Chinese acupunc- ture.15 The six prescribed acupuncture needles generally tooka few minutes to insert. Acupuncture needles were stimulated by manual rotation of the needle to evoke needle sensation The study was designed as a prospective, randomised con- (De Qi). No electrostimulation was used. Acupuncture nee- trolled clinical trial. The trial was initiated in May 2006, dles were covered with silicone, which facilitates easy incision and inclusion of participants stopped in July 2007. The trial and removal (Seirin GMBH, Jeu-Isenburg, Germany).
was conducted at Sønderborg Hospital, Denmark. This hos- Charts and photographs showing the acupuncture points pital has approximately 1600 annual deliveries, and 36 mid- and needle insertion techniques were available in all delivery wives were trained to perform ear acupuncture treatment.
suites for display during the trial.
Clinical setting and standards of practice in Local anaesthetics relation to surgical repair Local anaesthetics were the usual pain-relief method in the All midwives working at the delivery ward were experienced department for most postpartum surgical repairs. The mid- in the use of acupuncture for general pain relief during wife was encouraged to use the amount estimated necessary labour. Standard acupuncture points for obstetric purposes with an upper limit of 20 ml. Lidocaine 10 mg/ml local anaes- were primarily located on the hands, arms, legs and on the thetic was applied directly into the wound using a plastic back as described by Chinese acupuncture traditions.15 Prior syringe with an appropriately sized needle. Suturing could to enrolment of participants in this trial, all 36 midwives were start after 5 minutes.
trained to provide ear acupuncture specifically for perinealpain relief in a 2-hour hands-on course. The course was chaired by a certified acupuncturist who also worked as a The primary outcome was pain experienced during surgical clinical midwife. When the first 100 participants were en- repair reported by women at 24–48 hours postpartum.
rolled, a mandatory individual 1-hour refresher workshop Secondary outcomes were need for additional pain relief, was arranged in order to secure uniformity of treatment wound healing assessed at 24–48 hours and 14 days postpar- throughout the trial period.
tum, participant evaluation, need for wound revision and ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology Pain relief during surgical repair postpartum superficial dyspareunia as reported 6 months postpartum.
(S.K.) or two research nurses. Interviews and wound-healing Other outcomes of interest were pain experienced during assessments were conducted in the hospital at 24–48 hours application of both pain-relief methods and pain from the and 14 days postpartum. The research midwife or nurse filled sutured area during healing postpartum.
out the questionnaires during the interview and after inspec-tion of wound healing. The final follow-up interview at Eligibility and recruitment 6 months postpartum was conducted as a telephone interview.
All healthy primiparous women with intended vaginal deliv- Pain was assessed using a simple Verbal Descriptive Pain ery at Sønderborg Hospital, Denmark, received written Scale (no pain, mild pain, moderate pain or severe pain). The patient information about the trial at antenatal visits. The Visual Analogue Scale (VAS) was used for evaluation of pain written informed consent was obtained prior to inclusion into intensity.18 Wound healing was evaluated by assessing the trial if the midwife diagnosed a laceration that required whether the wound was gaping more than 0.5 cm as well as suturing, and the patient was still willing to participate. Pri- by systematic evaluation of Redness, Edema, Ecchymosis, miparous women were eligible if they expected a healthy child Discharge and Approximation (the REEDA scale).19 The and had a spontaneous or instrumental delivery using a questionnaires were developed on the basis of questionnaires ventouse after 36 weeks of gestation. The surgical repairs used in similar trials in the UK and Denmark.4,9,20 included in this trial were lacerations in the labia, vaginalmucosa, superficial perineal tissue (first or second degree) or mediolateral episiotomy. Participants were required to The power calculation was based on an assumption of a 20% understand Danish.
absolute difference in numbers of expected ‘pain-free surgical Exclusion criteria were delivery by forceps, perineal injuries repairs' following the use of ear acupuncture. In a previous involving the anal sphincter and/or anal mucosa (third or trial using similar local anaesthetics, 50% of the participants fourth degree), postpartum haemorrhage >1000 ml, previous reported pain during perineal repair.9 In order to detect an perineal surgery or severe mental illness. The laceration increase from 50 to 70% or a decrease from 50 to 30% with should not have extended into the anal sphincter complex, the power of 80% and an alpha of 0.05, a total of 206 partic- as these repairs were usually sutured by an experienced obste- ipants were needed for the trial.
trician under spinal analgesia in the operating theater. Enrol-ment of patients with epidurals into the trial was onlypossible, if the patient requested additional pain relief prior to surgical repair. In this case a ‘top-up' of the epidural was Trial analyses and reports were made in accordance with not offered and women were randomised to one pain-relief CONSORT requirements.21 All statistical analyses were per- method or the other as described in the study protocol.
formed based on the intention-to-treat principle. Data wereentered twice into the software program EpiData Entry ver- sion 3.1 in order to correct for typing errors (The EpiData Randomisation was made by the use of touch-tone telephone Association, Odense, Denmark). Stata statistical software keys using the participant's unique personal identification version 8.2 was used for analysis (StataCorp College Station, number with a computer-assisted Voice Response System.
In order to ensure equal distribution in treatment groups, Two-sample t tests were used for analyses of continuous the randomisation programme stratified patients by epidural data with normal distribution. Mean values were reported for pain relief during delivery and whether an episiotomy had with SD. Continuous data without normal distribution were been performed. The midwife in charge of the delivery was analysed by the Mann–Whitney U test and median values responsible for conducting the allocated treatment to suture were reported with 10/90% percentiles. The chi-square test the laceration and to fill in special trial forms.
was used for analyses of categorical variables. The Fisher'sexact test was used if expected frequencies were less than five.
All statistical tests were two tailed, and P values <0.05 were The trial was single blinded on the part of the research team considered statistically significant. Risk ratios (RR) and 95% responsible for postnatal interviews, inspections of wound CI are shown for selected binary outcomes.
healing and data entry into the research database. All trialparticipants were encouraged not to disclose their random- isation group during follow up.
During the randomisation period, 623 primiparous women delivered vaginally. Of these, 207 were randomised. A total of All participants were interviewed using structured question- 105 women were allocated to ear acupuncture and 102 to local naires. The interviews were performed by a specialist midwife anaesthetics. Two women were enrolled without meeting the ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology Kindberg et al.
inclusion criteria but remained in the trial according to the wound healing were performed within the intended time lim- intention-to-treat principle (Figure 1).
its for follow up (Table 2).
The follow-up rate was 99% at 24–48 hours, 97% at 14 days Blinding of the interviewer was assessed during the trial.
and 92% at 6 months postpartum (Figure 1). The two groups The blinding during interviews was successful in 63% within were comparable in terms of baseline characteristics, distri- the acupuncture group and 64% in the local analgesia group bution of genital tract injury and usage of obstetric acupunc- (P = 0.99). Additional pain-relief methods were more com- ture during labour. The use of epidural for pain relief during monly used in the acupuncture group than among those allo- labour was comparable (Table 1). No side-effects were cated to local anaesthetics (Table 2).
reported in either treatment group.
Pain during surgical repair was more frequently reported Treatment with either pain-relief method was provided by by women allocated to ear acupuncture than those receiving 36 different midwives during the study period. The average local anaesthetics (Table 3). The median VAS score was sig- number of enrolled participants per midwife was five nificantly higher in the ear acupuncture group compared with throughout the study period (range 1–18). No difference the local anaesthetics group: 3.5 versus 1.5, P < 0.01. Signif- was seen with respect to time for completion of repair or icantly more women also reported pain on a verbal descrip- usage of suture material. Compliance to allocated treatment tive scale and felt that the repair was uncomfortable (Table 3).
was 96% in both groups. The interviews and assessments of The ear acupuncture group more frequently received Assessed for eligibility (n = 623) Non-participants: (n = 416) Reasons: No laceration (n = 65) Anal sphincter injury (n = 20) Refused to participate (n = 77) Midwives too busy (n = 116) Midwives not trained (n = 39) Inclusion criteria not met (n = 99) (n = 207) Allocated to acupuncture: n = 105 Allocated to local anesthetics: n = 102 Compliance to method: 101 (96%) Compliance to method: 98 (96%) Additional pain relief used: 56 (53%) Additional pain relief used: 22 (22%) Follow up 24–48 hours: 104 (99%) Follow up 24–48 hours: 102 (100%) Follow up 14 days: 99 (94%) Follow up 14 days: 102 (100%) Follow up 6 months: 100 (93%) Follow up 6 months: 96 (92%) Analysed: n = 105 Analysed: n = 102 Intention-to-treat analysis Intention-to-treat analysis Figure 1. CONSORT flowchart. Vaginal deliveries in primiparous women during study period.
ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology Pain relief during surgical repair postpartum Table 1. Baseline characteristics for participants in trial Local anaesthetics MothersAge, years BabiesGestational age, days Birthweight, grams DeliveryAcupuncture used during labour Epidural used during labour Duration of second stage, minutes Sutured injury in genital tract*Labia minora First-degree perineal laceration Second-degree perineal laceration Third degree (enrolled in error) Data presented as number (%), mean (SD) or median (10–90% percentile).
*Genital tract trauma could be one or several of the mentioned. The total therefore exceeds 100%.
additional pain relief during surgical repair (53 versus 22%, declined to comparable levels at 14 days postpartum P < 0.01; RR 2.50, 95% CI 1.66–3.79,) (Table 3). Excluding (Table 3). Need for subsequent wound revision was rare patients with epidurals from the analysis of primary outcomes and did not differ between the two groups (Table 3). The did not change the conclusions (data not shown).
occurrence of dyspareunia was similar in the two groups However, no difference was seen in numbers of patients who 6 months postpartum (Table 3).
would have preferred more analgesia (14 versus 8%, P = 0.14).
Patient satisfaction with allocated pain-relief method eval- No difference was seen in wound healing at 24–48 hours or uated 14 days postpartum was lower in the ear acupuncture 14 days postpartum. Comparable proportions of wounds group (69 versus 91%, P < 0.01). Fewer women in the were gaping at 24–48 hours, and these proportions also ear acupuncture group would recommend it to a friend Table 2. Treatment after inclusion into trial and precision of data collection Ear acupuncture (n 5 105) Local anaesthetics (n 5 102) Compliance to pain-relieving method Supplementary pain relief during repair* Entonox (N2O–O2) SuturingMinutes to perform repair Material used, packets Follow-up precision in trialHours from birth to first interview Days from birth to second interview Days from birth to third interview Data presented as number (%), mean (SD) or median (10–90% percentile).
*Additional pain relief provided by midwife during suturing on request from trial participants.
ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology Kindberg et al.
Table 3. Primary and secondary outcomes in trial Ear acupuncture (n 5 105) Local anaesthetics (n 5 102) Effectiveness of pain-relief methodVAS during repair (0.0–10.0 possible) Pain during repair (any pain) Verbal description of pain Wound healing and dyspareuniaREEDA score day 1–2 (0–15 possible) REEDA score day 14 (0–15 possible) Wound gaping day 1–2 (.0.5 cm) Wound gaping day 14 (.0.5 cm) Revision of wound area (6 months) Dyspareunia at first intercourse Dyspareunia at 6 months postpartum Patient evaluationWould prefer more analgesia* Felt repair was uncomfortable* Satisfied with pain-relieving method** Would recommend method to friend** Would choose same method again** Generally satisfied with repair** REEDA (the REEDA scale): Redness, Edema, Ecchymosis, Discharge and Approximation. Data presented as number (%), mean (SD) or median (10–90%percentile).
*Question answered in questionnaire 1–2 days postpartum.
**Question answered in questionnaire 14 days postpartum.
(74 versus 91%, P < 0.01). Willingness to choose the same tion of the pain-relief method itself was less painful when ear pain-relief method at a future delivery did not differ between acupuncture was provided compared with local anaesthetics the groups, and an equal proportion of women were generally (VAS 1.5 versus 2.1, P = 0.02) (Table 4). In the ear acupunc- satisfied with the repair (Table 3).
ture group 59% felt pain when the method was applied com- Patient evaluation of pain and discomfort during applica- pared with 68% among those allocated to local anaesthetics tion of either pain-relief method was also evaluated. Applica- (P = 0.15) (Table 4).
Table 4. Pain during application of pain-relief method and pain in wound area postpartum Local anaesthetics Evaluation of application of pain-relieving methodVAS score for application of method Application was painful 0.86 (0.70–1.06) Application was uncomfortable 0.37 (0.19–0.70) Pain from wound area postpartumVAS Score at 24–48 hours VAS Score At 14 days postpartum Any pain in wound area at 24–48 hours 0.80 (0.65–0.98) Any pain in wound area at 14 days postpartum 0.97 (0.51–1.88) Oral analgesia usage at 24–48 hours 1.05 (0.52–2.11) Oral analgesia usage at 14 days postpartum 1.94 (0.18–21.1) Data presented as number (%) and median (10–90% percentile).
*Fisher's exact test.
ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology Pain relief during surgical repair postpartum Pain from the wound 24–48 hours postpartum was also less of acupuncture. This may have influenced the trial results in common in women randomised to ear acupuncture (RR 0.80, any direction depending on the midwives' attitude towards 95% CI 0.65–0.98). The median VAS score at this point was also lowest in the acupuncture group, although the difference The questionnaires in this trial were filled out by research- was non-significant (VAS 1.9 versus 2.7, P = 0.06). Pain from ers during interviews with trial participants. A potential dis- the wound decreased over time, and at 14 days postpartum no advantage of this data collection strategy was the information difference was seen between the groups (Table 3). No differ- bias that could occur as trial participants might have re- ence was seen in use of oral analgesia.
sponded differently if the same questions were asked in self-administered questionnaires. Another limitation in the datacollection method was the potential for recall bias as patients reported their experience during surgical repair 1–2 days afterdelivery. Most of the reported pain scores were in the ‘mild' We found that ear acupuncture as provided in this study was end of the verbal descriptive scale and in the lower end of the less effective for pain relief during postpartum surgical repair VAS scale. This might reflect the relatively small extent of than local anaesthetics. More patients were satisfied with the trauma as most participants had sutures in the labia area or pain-relief method if local anaesthetics had been used. How- minor perineal lacerations only. Although trial participants ever, the wound healing was reported as less painful if ear reported more pain and less satisfaction when they were rand- acupuncture had been used during repair.
omised to ear acupuncture, this did not seem to affect their Immediate postpartum wound healing was similar in the willingness to choose ear acupuncture for pain relief after two study groups. Long-term healing indicators, such as a subsequent delivery. This contradiction was by most partic- need for revision of wound or dyspareunia, were also not ipants explained as a strong wish to give birth without use of any pharmacological interventions.
To evaluate a low-budget training programme we set out to Improving postpartum pain-relief methods for surgical evaluate a brief training package of a 2-hour hands-on work- repair of genital laceration during childbirth is important.
shop for a group of midwives with some previous experience Ear acupuncture for pain relief during postpartum surgical in the use of acupuncture. This design was chosen as a prag- repair as used in this trial was less effective compared with matic solution in order to evaluate a realistic clinical situation local anaesthetic using Lidocaine 1% for repair of superficial of implementing a new pain-relief method. Acupuncturists genital tract lacerations. From a quality improvement point of might argue that the ability to offer relevant treatment with view, the question should be asked whether our current ‘best ear acupuncture requires far more training and practice in practice' with the use of local anaesthetics is good enough, order to maintain a certain competence level. The average when some 68% report pain when pain relief is applied in the number of participants per midwife was 5 (range 1–18) over wound area, and another 54% report some degree of pain the study period of 15 months. Thus, it is plausible that not all during surgical repair. Further trials aiming to improve the midwives who provided ear acupuncture for pain relief in this effectiveness and acceptability of pain-relief methods are trail were sufficiently qualified at the time of enrolment of required. A general concern for research within manual- participants. The limited number of enrolled participants per and clinician-dependent therapies is how to ensure that clin- midwife limits the possibility to analyse data for any time ical staff has acquired sufficient skills in providing the trend as a trace of a learning curve.
healthcare intervention that is evaluated. Evidence is The gold standard for evaluation of new treatments within required on how best to evaluate clinical competence and health science is the double-blind controlled trial.22 Blinding manual skills within the use of acupuncture. Ear acupunc- should ideally be on three levels: the care provider, the patient ture and acupuncture in general have proved very effective and the researcher. In this trial, only the investigator was for some types of pain and discomfort. We suggest that blinded and some questions may be raised about the effect future trials evaluate more elaborate training packages of of placebo. However, double blinding was not possible in this the involved staff.
trial. A pretrial pilot test of placebo acupuncture and placebolocal anaesthetics indicated that blinding of participants and Conflict of interests midwives was unrealistic because both were able to identify There are no conflicts of interest.
the active treatment. The swelling of the tissue after applica-tion of local anaesthetics or placebo could not be camou- Contribution to authorship flaged. Experienced acupuncturists might also argue that Sara Kindberg and Lis Klu¨nder conceived the idea for this trial and placebo acupuncture in the ear would not be possible because wrote the study protocol, coordinated training of the involved staff, of the very superficial location of the acupuncture points.23 planned data collection and performed data analyses. Jens Strøm The midwives in this trial had different attitudes to the effect and Tine Brink Henriksen contributed to study design, funding ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology Kindberg et al.
applications and supervised study implementation and data collec- 6 Dencker A, Lundgren I, Sporrong T. Suturing after childbirth—a ran- tion. All authors contributed to the writing and editing of this article.
domised controlled study testing a new monofilament material. BJOG2006;113:114–16.
Details of ethics approval 7 Mackrodt C, Gordon B, Fern E, Ayers S, Truesdale A, Grant A. The The regional scientific ethics committee approved the trial (J.no: Ipswich Childbirth Study: 2. A randomised comparison of polyglactin 2006-1011) and the trial was registered with the Danish Data Pro- 910 with chromic catgut for postpartum perineal repair. Br J Obstet tection Agency (J.no: 2006-53-1300).
8 Fyneface-Ogan S, Mato CN, Enyindah CE. Postpartum perineal pain in primiparous women: a comparison of two local anaesthetic agents.
Niger J Med 2006;15:77–80.
The Department of Obstetrics and Gynecology at Sønderborg Hos- 9 Kindberg S, Stehouwer M, Hvidman L, Henriksen TB. Postpartum per- pital, Denmark provided funding for this trial. Funding was also ineal repair performed by midwives: a randomised trial comparing two provided by the Danish Midwifery Organisation, the Aase and Einar suture techniques leaving the skin unsutured. BJOG 2008;115:472–9.
Danielsen Foundation, the Augustinus Foundation, the Sophus 10 Sanders J, Peters TJ, Campbell R. Techniques to reduce perineal pain Jacobsen Foundation and the Frode Nygaard Foundation. Econom- during spontaneous vaginal delivery and perineal suturing: a UK survey ical assistance did not influence the research design, data collection, of midwifery practice. Midwifery 2005;21:154–60.
data analyses or publication of the results.
11 Lee H, Ernst E. Acupuncture for labor pain management: a systematic review. Am J Obstet Gynecol 2004;191:1573–9.
12 Borup L, Wuritzer W, Hedegaard M, Kesmodel U, Hvidman L. Acu- puncture as pain relief during delivery - a randomized controlled trial.
We wish to thank the women who participated in the trial and the Birth 2009 (in press).
many midwives at Sønderborg Hospital, Denmark whose contri- 13 Martensson L, Stener-Victorin E, Wallin G. Acupuncture versus sub- butions made this research possible. We also wish to thank Con- cutaneous injections of sterile water as treatment for labour pain. Acta sultant Obstetrician and Gynaecologist, Kirstine Mu¨nster, Hillerød Obstet Gynecol Scand 2008;87:171–7.
Hospital, Denmark, for her contribution on selecting the relevant 14 Smith CA, Collins CT, Cyna AM, Crowther CA. Complementary and acupuncture points used in this trial. j alternative therapies for pain management in labour. Cochrane Data-base Syst Rev 2006;4:CD003521.
15 Carlsson C, Anckers L. Akupunktur och TENS inom obstetriken, 1st edn. Lund: Studenterlitteratur, 1997.
16 Kettle C, Hills RK, Ismail KM. Continuous versus interrupted sutures for 1 Albers L, Garcia J, Renfrew M, McCandlish R, Elbourne D. Distribution repair of episiotomy or second degree tears. Cochrane Database Syst of genital tract trauma in childbirth and related postnatal pain. Birth 17 Oleson T. Auriculotherapy Manual. Chinese and Western Systems of 2 Royal College of Obstetricians and Gynaecologists. The management Ear Acupuncture, 3rd edn. Amsterdam: Churchill Livingstone, 2003.
of third- and fourth-degree perineal tears. Green-top Guideline No. 29, 18 Scott J, Huskisson EC. Graphic representation of pain. Pain 1976;2: London: RCOG Press, 2007.
3 Gordon B, Mackrodt C, Fern E, Truesdale A, Ayers S, Grant A. The 19 Davidson N. REEDA: evaluating postpartum healing. J Nurse Midwifery Ipswich Childbirth Study: 1. A randomised evaluation of two stage postpartum perineal repair leaving the skin unsutured. Br J Obstet 20 Fleming N. Can the suturing method make a difference in postpartum perineal pain? J Nurse Midwifery 1990;35:19–25.
4 Kettle C, Hills RK, Jones P, Darby L, Gray R, Johanson R. Continuous 21 Altman DG. Better reporting of randomised controlled trials: the versus interrupted perineal repair with standard or rapidly absorbed CONSORT statement. BMJ 1996;313:570–1.
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22 Piantadosi S. Clinical Trials. A Methodologic Perspective, 1 edn. Hoboken, NJ: John Wiley & Sons, Inc., 1997.
5 Oboro VO, Tabowei TO, Loto OM, Bosah JO. A multicentre evaluation 23 White P, Lewith G, Hopwood V, Prescott P. The placebo needle, is it of the two-layered repair of postpartum perineal trauma. J Obstet a valid and convincing placebo for use in acupuncture trials? A ran- domised, single-blind, cross-over pilot trial. Pain 2003;106:401–9.
ª 2008 The Authors Journal compilation ª RCOG 2008 BJOG An International Journal of Obstetrics and Gynaecology
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