Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy

May 7, 2017 updated by: Alaa Elfeky, Ain Shams Maternity Hospital

Misoprostol With And Without Transcervical Balloon Catheter In Second Trimester Termination Of Pregnancy: A Randomized Controlled Trial

This randomized controlled study will be performed to compare the benefits and risks associated with the administration of misoprostol with or without the use of a transcervical balloon catheter to terminate pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be conducted at Ain Shams Maternity Hospital. An open-label, parallel-arm, randomized controlled trial between two groups; each consisting of 54 women, undergoing termination of pregnancy during the second trimester for various medical reasons. The first group will receive the standard misoprostol protocol for termination of second trimester pregnancy currently practiced at Ain Shams Maternity Hospital; 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours till complete expulsion of the uterine contents or surgical interference is decided. The second group will receive the exact same regimen, but will have in addition a transcervical balloon (Foleys') catheter that will be inflated with 30 ml. of fluid; and will have weighted traction applied to the catheter through using a 1000 ml fluid-filled bag in order to apply continuous pressure to the cervix. The target sample size was calculated to be 108 cases; randomization will be in a ratio of 1:1 using a computer-generated random sequence. Allocation will be concealed using sealed, opaque consecutively-numbered envelopes. Women are counseled about the procedure, consenting women will thus be randomly assigned to one of the groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Cairo
      • Cairo Governorate, Cairo, Egypt, 11591
        • Recruiting
        • Ain Shams University Maternity Hospital
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: pregnancy in the second trimester (defined as gestational age between 14 and 28 weeks of gestation) with a medical indication for termination of pregnancy.

-

Exclusion Criteria:

-

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Misoprostol
This group will receive 400 micrograms of misoprostol administered vaginally for the first dose, followed after 6 hours by 400 micrograms administered orally, repeated every 6 hours.
Drug: Misoprostol
400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion
Other Names:
  • Cytotec
  • Misotac
Experimental: Misoprostol/Transcervical catheter
This group will receive the same regimen, but will have in addition a transcervical balloon (Foleys') catheter that is inflated with 30 ml. of fluid; with weighted traction using a 1000 ml fluid-filled bag applying continuous pressure to the cervix
Drug: Misoprostol
400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion
Other Names:
  • Cytotec
  • Misotac
Device: Misoprostol/Transcervical catheter
Foleys' catheter introduced into the cervix and inflated with 30 ml. of fluid; weighted traction applied by using a 1000 ml fluid-filled bag
Other Names:
  • Foley catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Induction-expulsion interval
Time Frame: 48 hours from starting intervention
The duration from the administration of the first misoprostol dose vaginally till complete expulsion of the uterine contents; complete uterine emptiness will be confirmed by ultrasonographic assessment
48 hours from starting intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total required doses of misoprostol
Time Frame: 48 hours from starting induction
The total amount of misoprostol used per participant during the procedure
48 hours from starting induction
The need for surgical interventions
Time Frame: 1 week from starting induction
The number of participants requiring any surgical intervention under anesthesia to complete uterine emptiness
1 week from starting induction

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams Maternity Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alaa Elfeky, Professor, Ainshams University maternity hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OBINTVN1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available after publication of the study upon formal request by researchers and research centers that collaborate with Ain Shams Maternity Hospital. Data could be obtained through contacting PI by email.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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