A Pilot Study of Priming Before Induction Termination of Pregnancy

October 3, 2008 updated by: Boston University

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.

Study Overview

Detailed Description

This is a prospective series. All women enrolled will receive the same treatment. 10 women without prior births and 10 women with prior births will be enrolled. 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.

Inclusion criteria: Women who have requested induction abortion and completed the counseling and consent process for abortion. Women 18 years of age or over. Capable of giving informed consent. Speak English or Spanish Pregnancy 18-23 weeks. No contraindication to misoprostol abortion

Exclusion criteria: Unable to understand and give informed consent. 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 any of the agents used for misoprostol induction abortion

After women have started the abortion process (completed counseling and consent for abortion, and completed the fetocidal digoxin injection), they will be approached by one of the investigators. The procedures and the consent process will be explained. If they consent, they will be given an envelope which contains 50 mcg of misoprostol (1/2 of a 100 mcg tablet). They will be instructed to place the tablet buccally and hold it in place for 30 minutes, after which it can be swallowed, between 8 and 9 pm that evening.

They will return at 7 am the next morning; the actual induction process starts between 8 and 10 am depending on the bed situation. The reminder of the care is identical to women not in the study and consists of misoprostol 400 every 6 hours. The only step that will be from the current induction process is the administration of the priming dose the night before.

The duration of participation for individuals is up to 48 hours. The study overall will take one year.

Analytic plan:

This is a pilot study to estimate the effect on induction times, and to monitor for any adverse events. This pilot will be the basis of further study.

When the sample size is 19, a two-sided 95.0% confidence interval for a single mean will have an interval that extends no more than 1.5 from the observed mean, assuming that the true standard deviation is 3.25 and that the confidence interval is based on the t statistic. The "typical" mean is 14 hours and the 95% confidence interval around 12.5 hours is 11hours to 14 hours.

The primary outcome is the induction time, the time from start of induction until fetal expulsion. As there are about 80 induction procedures per year, and past studies have enrolled 50-60% of eligible women, it will take approximately 6 months to complete enrollment.

The length of induction will be described and the mean will be contrasted to a typical value (14 hours) . Minor events such as nausea will be tabulated. There will be a sub-analysis of outcome by parity (women without prior births compared to women with prior births). This study is not powered to show differences between these two groups but this information wil be helpful in planning future studies.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18 years of age or over
  • able to give informed consent in English or Spanish
  • requesting termination of pregnancy
  • pregnancy 18-23 weeks of gestation

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Length of time between the start and the finish of the induction
Time Frame: 24 h
24 h

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of nausea and cramping
Time Frame: 24 h
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nilda L Moreno-Ruiz, MD, Boston University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

June 29, 2007

First Submitted That Met QC Criteria

July 2, 2007

First Posted (Estimate)

July 3, 2007

Study Record Updates

Last Update Posted (Estimate)

October 7, 2008

Last Update Submitted That Met QC Criteria

October 3, 2008

Last Verified

October 1, 2008

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Abortion, Induced

Clinical Trials on Addition of misoprostol 25 mcg 12 hours before induction

3
Subscribe