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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01436266
Other study ID # H-30452
Secondary ID
Status Terminated
Phase Phase 3
First received September 15, 2011
Last updated March 18, 2014
Start date July 2011
Est. completion date August 2012

Study information

Verified date March 2014
Source Boston University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to aid in softening the cervix as well as decreasing blood loss after abortion or vaginal delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester surgical abortion decreases blood loss from the procedure. The investigators will also assess whether misoprostol improves cervical dilation, changes the length of the procedure, changes the need for additional mechanical dilation, changes the subjective ease of the procedure, and changes a woman's pain.


Recruitment information / eligibility

Status Terminated
Enrollment 2
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- English or Spanish speaking

- Gestational age between 16 weeks 6 days and 20 weeks 6 days gestation by ultrasound dating on the day of enrollment

- Ultrasound used for dating purposes must be within the last two weeks.

- Women 18-50 years of age undergoing surgical termination of pregnancy

Exclusion Criteria:

- Spontaneous fetal demise

- Ruptured membranes or intrauterine infection

- Fibroids that significantly distort the uterine shape

- Uterine abnormality such as unicornuate uterus

- Prior transmural myomectomy

- Severe oligohydramnios

- Morbid obesity with BMI>45

- Inability to place osmotic dilators

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Misoprostol
200 mcg buccally prior to procedure
Folic acid
2mg buccally 2 hours prior to procedure

Locations

Country Name City State
United States Boston University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss Measured blood loss Subjects will be followed for the duration of their procedure visit, lasting one day. Yes
Secondary Cervical dilation Subjects will be followed for the duration of their procedure visit, lasting one day. Yes
Secondary Length of the procedure Subjects will be followed for the duration of their procedure visit, lasting one day. No
Secondary Need for additional mechanical dilation Subjects will be followed for the duration of their procedure visit, lasting one day. Yes
Secondary Subjective provider ease of procedure Subjects will be followed for the duration of their procedure visit, lasting one day. No
Secondary Subject pain before the procedure Subjects will be followed for the duration of their procedure visit, lasting one day. No
Secondary Subject pain during the procedure Subjects will be followed for the duration of their procedure visit, lasting one day. No
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