NCT03025581

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 6, 2017

Last Update Submit

January 16, 2017

Conditions

Premature Rupture of Fetal Membranes

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    One year

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Nipple stimulation.

Other: Nipple stimulation

Control group

NO INTERVENTION

No intervention (expectant management only).

Interventions

Nipple stimulationOTHER

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.

Intervention group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Israel

Location

Related Publications (12)

  • Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.

    PMID: 8598837RESULT

  • Cahill AG, Tuuli MG. Labor in 2013: the new frontier. Am J Obstet Gynecol. 2013 Dec;209(6):531-4. doi: 10.1016/j.ajog.2013.04.016. Epub 2013 Apr 10.

    PMID: 23583208RESULT

  • Christensson K, Nilsson BA, Stock S, Matthiesen AS, Uvnas-Moberg K. Effect of nipple stimulation on uterine activity and on plasma levels of oxytocin in full term, healthy, pregnant women. Acta Obstet Gynecol Scand. 1989;68(3):205-10. doi: 10.3109/00016348909020990.

    PMID: 2618602RESULT

  • Elliott JP, Flaherty JF. The use of breast stimulation to ripen the cervix in term pregnancies. Am J Obstet Gynecol. 1983 Mar 1;145(5):553-6. doi: 10.1016/0002-9378(83)91194-8.

    PMID: 6338721RESULT

  • Elliott JP, Flaherty JF. The use of breast stimulation to prevent postdate pregnancy. Am J Obstet Gynecol. 1984 Jul 15;149(6):628-32. doi: 10.1016/0002-9378(84)90247-3.

    PMID: 6377899RESULT

  • Hill WC, Moenning RK, Katz M, Kitzmiller JL. Characteristics of uterine activity during the breast stimulation stress test. Obstet Gynecol. 1984 Oct;64(4):489-92.

    PMID: 6483296RESULT

  • Johnson JW, Daikoku NH, Niebyl JR, Johnson TR Jr, Khouzami VA, Witter FR. Premature rupture of the membranes and prolonged latency. Obstet Gynecol. 1981 May;57(5):547-56.

    PMID: 7219903RESULT

  • Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003392. doi: 10.1002/14651858.CD003392.pub2.

    PMID: 16034897RESULT

  • Leake RD, Buster JE, Fisher DA. The oxytocin secretory response to breast stimulation in women during the menstrual cycle. Am J Obstet Gynecol. 1984 Feb 15;148(4):457-60. doi: 10.1016/0002-9378(84)90726-9.

    PMID: 6696003RESULT

  • 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.

    PMID: 24778358RESULT

  • Salmon YM, Kee WH, Tan SL, Jen SW. Cervical ripening by breast stimulation. Obstet Gynecol. 1986 Jan;67(1):21-4.

    PMID: 3940333RESULT

  • Viegas OA, Arulkumaran S, Gibb DM, Ratnam SS. Nipple stimulation in late pregnancy causing uterine hyperstimulation and profound fetal bradycardia. Br J Obstet Gynaecol. 1984 Apr;91(4):364-6. doi: 10.1111/j.1471-0528.1984.tb05924.x.

    PMID: 6712896RESULT

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Mordechai Hallak, M.D

    Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera

    PRINCIPAL INVESTIGATOR

  • Rinat Gabbay, M.D

    Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera

    STUDY DIRECTOR

Central Study Contacts

Ofer Limonad, M.D

CONTACT

oferlimonad@gmail.com

Esti Maor, M.D

CONTACT

estigal02@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 19, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)