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Completed

NCT Number: NCT00324519

Randomized Trial Comparing Misoprostol and Foley Bulb for Pregnancy Termination in the Second Trimester

The purpose of this study is to compare two methods of pregnancy termination on the time to delivery in the second trimester.

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Key information

Conditions

Pregnancy Trimester, Second Induced Abortion Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Shands Hospital at the University of Florida

Gainesville, Florida, 32610, United States

About this study

Medical termination in the second trimester is performed for many indications. Successful termination is dependant on ripening of the cervix prior to labor induction. Multiple methods of cervical ripening and labor induction have been used for pregnancy termination in the second trimester. These two methods have different mechanisms of action. This study seeks to evaluate the effectiveness of these two methods.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • indication for pregnancy termination, gestational age from 13-27 weeks

Exclusion criteria

  • multiple gestation, previous uterine surgery, rupture of membranes, latex allergy

Treatment and study plan

Foley bulb

Device

Misoprostol

Drug

Primary outcomes

  1. Time to vaginal delivery

Secondary outcomes

  1. Rate of chorioamnionitis

  2. Rate of maternal fever

  3. Rate of postpartum hemorrhage

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
May 11, 2006
Registry last updated
Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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