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Safety Study of Membrane Sweeping in Pregnancy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2006 by Tripler Army Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tripler Army Medical Center
ClinicalTrials.gov Identifier:
NCT00294242
First received: February 17, 2006
Last updated: NA
Last verified: February 2006
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Not yet recruiting
Tamc, Hawaii, United States, 96859
Contact: Holly Olson, M.D.    808-433-5953    holly.olson@haw.tamc.amedd.army.mil   
Principal Investigator: Micah J Hill, D.O.         
Sub-Investigator: Grant McWilliams, D.O.         
Sub-Investigator: Bruce Chen, M.D.         
Sub-Investigator: Nathan Hoeldtke, M.D.         
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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00294242     History of Changes
Other Study ID Numbers: 6H06
Study First Received: February 17, 2006
Last Updated: February 17, 2006
Health Authority: United States: Federal Government

Keywords provided by Tripler Army Medical Center:
pregnancy
membranes sweeping
prelabor rupture of membranes

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014