Safety Study of Membrane Sweeping in Pregnancy

NCT00294242 | Completed

• 1 other identifier: 6H06
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if routine membrane sweeping in uncomplicated term pregnancies increases the rate of pre-labor rupture of membranes.

Conditions

Pregnancy; Prelabor Rupture of Membranes

Keywords

pregnancy; membranes sweeping; prelabor rupture of membranes

Outcome Measures

Primary Outcomes (1)

• Prelabor membranes rupture

  Rates of prelabor rupture of membranes

  3 weeks

Study Arms (2)

Membrane Sweep

ACTIVE COMPARATOR

Weekly membrane sweeping performed for the duration of the pregnancy after 38 0/7 weeks gestational age

Procedure: Membrane Sweep

No Membrane Sweep

EXPERIMENTAL

No membrane sweeping conducted for the duration of the pregnancy after 38 0/7 weeks gestational age

Procedure: No Membrane Sweep

Interventions

Membrane Sweep PROCEDURE

Weekly Membrane Sweep

Membrane Sweep

No Membrane Sweep PROCEDURE

No Membrane Sweep

No Membrane Sweep

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Uncomplicated, singleton pregnancies
• candidates for vaginal delivery
• to 42 weeks estimated gestational age

You may not qualify if:

• multiple gestation
• placenta previa
• placental abruption
• pre-gestational or gestational diabetes
• chronic or gestational hypertension
• pre-eclampsia
• pregnancy before 38 weeks gestation
• any pregnancy with an indication for induction other than impending post dates
• any pregnancy not planning of vaginal delivery
• history or preterm labor or prelabor rupture of membranes
• vasa previa
• cervical dilation 3cm or greater upon entry to study
• active cervical infection
• third trimester vaginal bleeding
• significant maternal mullerian anomalies

Sponsors & Collaborators

• Tripler Army Medical Center: lead

Study Sites (1)

Tripler Army Medical Center

Tripler AMC, Hawaii, 96859, United States

Location

Related Publications (2)

• 1. Bulware et al. Membrane sweeping for induction of labor. The Cochrane Database for induction of labor 2005, 2 (no page number) 2. Magann et al. Can we decrease postadtism in women with an unfavorable cervix and a negative fetal fibronectin test result at term by serial membrane sweeping? Am J Obstet Gynecol 1998, 179(4): 890-894 3. CammuH, Haitsma V. Sweeping membranes at 39 weeks in nulliparous women: a randomized controlled trial. Brit J Obstet Gynecol 1998: 105(1): 41-4 4. Boulvain et al. Does sweeping of the membranes reduce the need for formal induction of labour? A randomized controlled trial. Brit J Obstet Gynecol. 1998, 105(1): 34040 5. Allott HA, Palmer CR. Sweeping the membranes: a valid procedure in stimulating the onset of labour? Brit J Obstet Gynecol 1993, 100(10): 889-90 6. Wong et al. Does sweeping of membranes beyond 40 weeks reduce the need for formal incution of labour? Brit J Obstet Gynecol 2002, 109(6): 632-6 7. Sweeping of the membranes is an effective method of induction of labor in prolonged pregnancy: a report of a randomized trial. Brit J Obstet Gynecol 1992, 100(10): 898-903 8. McColgin et al. Partuitional factors associated with membrane stripping. Am J Obstet Gynecol. 1993, 169(1): 71-77 9. Keirse et al. Chronic stimulation of uterine prostaglandin synthesis during cervical ripening before the onset of labor. Prostaglandins, 1983, 25(5): 671-82 10. Goldenberg et al. Stretching of the cervix and stripping of the membranes at term: a randomized controlled study. Eur J Obstet Gynecol 1996, 66(2): 129-32 11. Tannirandorn Y, Jumrustanasan T. A comparative study of membrane stripping and nonstripping for induction of labor in term pregnancy. J Med Assoc of Thailand 1999, 82(3): 229-32 12. Williams Obstetrics. McGraww-Hill Companies. New York, NY. 2000, 440-1. 13. Maternal-Fetal Medicine. WB Saunders. Philedelphia, PA. 1999. 644-5. 14. Induction of Labor. Compendium of Selected Publications. ACOG Practice Bulletin. Nunmber 10, Nov 1999, 437-482. Merck, Washington, DC 2005. 15. De Grace et al. Induction of labour with a favourable cervix and/or pre-labour rupture of membranes. Clin Obstet Gynaecol. 2003 Oct;17(5):795-809. 16. Misoprostol versus expectant management in premature rupture of membranes at term. Brit Jour Obstet Gynecol. 2005 Sep;112(9):1284-90. 17. Permature Rupture of Membranes. ACOG Practice Bulletin. Number 1, June 1998, pgs 697-705. 18. Sahraoui W. et al. Management of pregnancies beyond forty-one week's gestation with an unfavorable cervix. J Gynecol Obstet Biol Reprod (Paris). 2005 Sep;34(5):454-62.

  BACKGROUND

• Hill MJ, McWilliams GD, Garcia-Sur D, Chen B, Munroe M, Hoeldtke NJ. The effect of membrane sweeping on prelabor rupture of membranes: a randomized controlled trial. Obstet Gynecol. 2008 Jun;111(6):1313-9. doi: 10.1097/AOG.0b013e31816fdcf3.

  PMID: 18515514 DERIVED

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Micah J Hill, D.O.

  United States Army

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 20, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

US (1)