Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion

Blood Loss Clinical Trial

— Preop Miso  

Official title:

Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01436266
• Other study ID #: H-30452
• 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

• Abortion
• Blood Loss
• Hemorrhage

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