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Intrapartum nipple stimulation therapy for labor induction: a randomized controlled external pilot study of
Elisabeth L Stark1, Zoe G Athens1, Moeun Son2
1From the Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale New Haven Hospital, New Haven, CT (Drs Stark and Athens).
Background:
Nipple stimulation is purported as a natural and inexpensive method for inducing labor, but its use is understudied.
Objective:
We aimed to assess whether conducting a large randomized controlled trial comparing intrapartum nipple stimulation therapy with oxytocin infusion is feasible and acceptable to patients and obstetrical care providers.
Study Design:
This single-center parallel-group randomized controlled external pilot study (ClinicalTrials.gov Identifier NCT04756089) included women at ≥36 weeks of gestation who were planned to receive exogenous oxytocin for their labor induction. Women who were <18 years old, non-English speaking, or with fetuses at increased risk of neonatal intensive care were excluded. Stratified by parity, women were randomized 3:1 to intrapartum nipple stimulation therapy or immediate receipt of oxytocin. Women assigned to nipple stimulation therapy were asked to stimulate with an electric breast pump or by hand for periods of at least 30 minutes, with breaks as needed for up to 15 minutes at a time, for at least a cumulative 2 hours before considering initiation of oxytocin, and to complete intrapartum diaries. Labor characteristics and outcomes were examined. Validated questionnaires were used to assess the participants' pain level during the intervention, their sense of control during childbirth, and their breastfeeding success. Primary outcome measures were recruitment, adherence to study protocol and follow-up, and crossover rates.
Results:
A total of 620 women underwent labor induction from March 13, 2021 to June 23, 2021. Of 557 potentially eligible women, 53 were approached by available research staff. Of the 53 women, 24 (45%) consented and enrolled: 18 randomized to nipple stimulation and 6 randomized to oxytocin. Moreover, 1 woman assigned to nipple stimulation withdrew because of delay of clinical care and received oxytocin (crossover rate of 1/24 [4%]), and 1 woman assigned to oxytocin did not receive it because of spontaneous labor progress. All other participants followed their assigned intervention. The 17 women who performed nipple stimulation stimulated for a median duration of 198 (interquartile range, 125-291) minutes and required a median of 69 (interquartile range, 21-80) minutes of stimulation before achieving at least 3 contractions in a 10-minute window, averaged >30 minutes (also known as "adequate" contractions). Among those assigned to nipple stimulation therapy, 15 of 17 women (88%) later received oxytocin infusion before delivery. The median times from intervention start to delivery were 16.4 (interquartile range, 0.6-28.2) hours for women assigned to nipple stimulation and 20.6 (interquartile range, 14.2-23.4) hours for women assigned to oxytocin infusion. Of note, 12 women (50%) completed their postpartum study questionnaires.
Conclusion:
Random assignment to either intrapartum nipple stimulation therapy or oxytocin infusion for labor induction was feasible and acceptable to patients and obstetrical care providers.
