Safety Study of Membrane Sweeping in Pregnancy - Full Text View

Sponsored by:	Tripler Army Medical Center
Information provided by:	Tripler Army Medical Center
ClinicalTrials.gov Identifier:	NCT00294242

Purpose

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.

Condition	Intervention	Phase
Pregnancy Prelabor Rupture of Membranes	Procedure: membrane sweeping	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety Study
Official Title:	Does Routine Membrane Sweeping in Uncomplicated Term Pregnancies Increase the Rate of Prelabour Rupture of Membranes

Further study details as provided by Tripler Army Medical Center:

Primary Outcome Measures:

rates of prelabor rupture of membranes

Secondary Outcome Measures:

effects of patient age, gestational age, parity, race, cervical exam, post-graduate year level of physician or if the provider is a midwife or attending staff on rates of term PROM.
Effects of membrane sweeping on indication for admission, inductions, reason for induction, estimated gestational age at delivery, cervical exam at admission, Bishop’s score on admission, labor outcomes, route or delivery, pregnancy complications, neo

Estimated Enrollment:	300
Study Start Date:	February 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
severe fetal anamolies
active genital herpes infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294242

Contacts

Contact: Micah J Hill, D.O.	808-433-5943	micah.hill@haw.tamc.amedd.army.mil
Contact: Grant McWilliams, D.O.	808-433-1815	grant.mcwilliams@haw.tamc.amedd.army.mil

Locations

United States, Hawaii
Tripler Army Medical Center
TAMC, Hawaii, United States, 96859

Sponsors and Collaborators

Tripler Army Medical Center

Investigators

Principal Investigator:

Micah J Hill, D.O.

United States Army

More Information

Publications:

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.

Publications indexed to this study:

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.

Study ID Numbers:	6H06
Study First Received:	February 17, 2006
Last Updated:	February 17, 2006
ClinicalTrials.gov Identifier:	NCT00294242
Health Authority:	United States: Federal Government

Keywords provided by Tripler Army Medical Center:

pregnancy
membranes sweeping
prelabor rupture of membranes

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Rupture

ClinicalTrials.gov processed this record on January 16, 2009