Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM? (NIPROM)

January 16, 2017 updated by: Hillel Yaffe Medical Center

Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM? (NIPROM Study)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Nipple stimulation.
Other: Nipple stimulation
For the intervention group participants 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.
No Intervention: Control group
No intervention (expectant management only).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Mordechai Hallak, M.D, Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
  • Study Director: Rinat Gabbay, M.D, Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

January 6, 2017

First Submitted That Met QC Criteria

January 16, 2017

First Posted (Estimate)

January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

January 19, 2017

Last Update Submitted That Met QC Criteria

January 16, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0091-HYMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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