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

Premature Rupture of Fetal Membranes Clinical Trial

— NIPROM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03025581
• Other study ID #: 0091-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 16, 2017
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: January 2017
• Source: Hillel Yaffe Medical Center
• Contact: Ofer Limonad, M.D
• Email: oferlimonad[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Premature Rupture of Fetal Membranes
• Rupture

Intervention

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.

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (12)

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. Review. — View Citation

Christensson K, Nilsson BA, Stock S, Matthiesen AS, Uvnäs-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. — View Citation

Elliott JP, Flaherty JF. The use of breast stimulation to prevent postdate pregnancy. Am J Obstet Gynecol. 1984 Jul 15;149(6):628-32. — View Citation

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. — View Citation

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):100 — View Citation

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. — View Citation

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. — View Citation

Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2005 Jul 20;(3):CD003392. Review. — View Citation

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. — View 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. Review. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment		One year