A Pilot Study of Priming Before Induction Termination of Pregnancy
1 other identifier
interventional
25
1 country
1
Brief Summary
Induction termination of pregnancy (second trimester abortion) has a median time of 14 hours from the start of medication (misoprostol) to expulsion of the fetus. The objective of this study is to evaluate a method of 'priming' on the length of induction termination of pregnancy. "Priming" refers to the use of medication to ready the cervix and uterus so that the uterus is more sensitive to medication and contracts more effectively, and also refers to softening of the cervix so that there is less resistance to dilation. Priming is used extensively before induction of labor for term pregnancy and is also used extensively before surgical abortion in second trimester. We would like to add priming the evening before induction to the usual treatment and evaluate whether the length of the induction process is shortened. Women are admitted to the hospital in the morning to start misoprostol medication, and unless expulsion occurs within 8-10 hours, need to stay overnight. The study design is to give the priming dose 12 hours before admission. The outcome of interest is the induction time from the first dose on misoprostol in the hospital to expulsion of the fetus. This study aims to assess whether the use of misoprostol as a priming agent would be beneficial with women who undergo induction termination of pregnancy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2007
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Posted
Study publicly available on registry
July 3, 2007
CompletedOctober 7, 2008
October 1, 2008
6 months
June 29, 2007
October 3, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Length of time between the start and the finish of the induction
24 h
Secondary Outcomes (1)
incidence of nausea and cramping
24 h
Interventions
Misoprostol given buccally the night before induction
Eligibility Criteria
You may qualify if:
- years of age or over
- able to give informed consent in English or Spanish
- requesting termination of pregnancy
- pregnancy 18-23 weeks of gestation
You may not qualify if:
- Unable to understand and give informed consent
- Under 18 years of age
- Pregnancy less than 18 weeks or over 23 weeks on the day of enrollment
- Ruptured membranes or signs of infection (temperature over 100.6 F,WBC \>15K)
- Fetal demise, Multi-fetal pregnancy contraindication to misoprostol
- contraindication to misoprostol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Nilda L Moreno-Ruiz, MD
Boston University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2007
First Posted
July 3, 2007
Study Start
January 1, 2007
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
October 7, 2008
Record last verified: 2008-10