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

NCT01436266 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: H-30452
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abortion; Blood Loss

Outcome Measures

Primary Outcomes (1)

• Blood Loss

  500 cc or more

  one day following the procedure

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

400 mcg buccally 2 hours prior to procedure

Drug: Misoprostol

Placebo (Folic acid)

PLACEBO COMPARATOR

Two 1-mg tablets buccally 2 hours prior to procedure

Other: Folic acid

Interventions

Misoprostol DRUG

400 mcg buccally 2 hours prior to procedure

Also known as: Cytotec

Misoprostol

Folic acid OTHER

2mg buccally 2 hours prior to procedure

Also known as: Vitamin B9

Placebo (Folic acid)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Hemorrhage

Interventions

Misoprostol; Folic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

1 of the 3 consented subjects became ineligible due to spontaneous rupture of amniotic membranes prior to the abortion. Early study termination, the PI left the institution, and study records could not be located for secondary data outcomes.

Results Point of Contact

• Title: Sarita Sonalkar, MD
• Organization: Boston Medical Center

sarita.sonalka@bmc.org

617 414 7304

Study Officials

• Sarita Sonalkar, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 19, 2011
• Study Start: July 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)