Clinical trial NCT03025581: Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM?
Official title: Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM? (NIPROM Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Rupture of Fetal Membranes
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-01-19
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the onset of regular uterine contractions.

PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to 80% of cases occurring at term. Approximately 90% of patients' experience PROM enter spontaneous labor within 24 hours, but disagreement exists among health care providers on the optimal management of women with PROM, particularly the need for and timing of inductions.

Nipple stimulation is a non-medical natural method for induction of labor. Previous studies demonstrated its effectiveness for initiating labor within 72 hours in women with favorable cervices. The actual mechanism by which such a technique results in cervical ripening is not well understood.

In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with term PROM choosing expectant management.

Detailed description: The participants in the study will be randomized into two groups of expectant management (patients desire an active approach will be excluded).

All eligible participants will be randomly allocated to either intervention or control group. They will be followed from the time of presentation with rupture of membranes at the ER and until the time of delivery. Prophylactic antibiotics will be administered after 18 hours from rupture of membranes as per departmental policy.

On admission, and after validating inclusion criteria, women will be offered to join the study. For the intervention group women will be instructed to gently massage alternate breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing cream will be offered to facilitate the procedure according to individual preferences. In the control group all participants will be asked to avoid any breast stimulation during the study period.

For both groups maternal surveillance will include obstetrician assessment every 6 hours or per maternal request if painful contractions. Every assessment will include documenting maternal vital signs, sense of contraction, fetal cardiotocographic assessment and vaginal examination if painful contractions. After delivery,all participants will be requested to fill a satisfaction questionnaire.

Eligibility criteria: Inclusion Criteria:

* Primagravidas at term (\>37) weeks having PROM
* Singleton pregnancies
* Cephalic presentation
* Unfavorable cervix (Bishop score \<7)
* Desire an expectant management

Exclusion Criteria:

* Prior cesarean section/ uterine rupture / transmural uterine incision
* Non reassuring fetal heart rate monitoring (Category III)
* Signs of fetal or maternal infection
* Time elapsed since PROM \> 6 hours
* Meconium or blood-stained amniotic fluid
* Any contraindication for vaginal birth

Primary outcomes:
measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
name: Mordechai Hallak, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
name: Rinat Gabbay, M.D
role: STUDY_DIRECTOR
References:
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citation: Mishanina E, Rogozinska E, Thatthi T, Uddin-Khan R, Khan KS, Meads C. Use of labour induction and risk of cesarean delivery: a systematic review and meta-analysis. CMAJ. 2014 Jun 10;186(9):665-73. doi: 10.1503/cmaj.130925. Epub 2014 Apr 28.
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