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

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

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.

Study Overview

• Status: Terminated
• Conditions: Blood Loss; Abortion
• Intervention / Treatment: Drug: Misoprostol; Other: Folic acid

Detailed Description

This project is a placebo-controlled, double-blinded randomized controlled trial comparing the effect of misoprostol 400mcg buccally to placebo on blood loss in second trimester surgical abortion between 16-21 weeks gestation. The probability of group assignment is 50% with half of the women randomized to misoprostol and half to placebo (folic acid 1 mg).

Folic acid was chosen at the placebo as it looks similar to misoprostol, and when it is held in the cheek it has very little taste, similar to misoprostol. A compounded placebo that was tasteless had a very different appearance and was not suitable as a control.

Consent will be obtained after consent for the abortion has been completed and counseling and explanation of the abortion has been completed. Consent may be obtained before the abortion procedures have begun of the day prior to abortion (osmotic dilator placement and induction of fetal demise if appropriate), or after these procedures have been completed. No study procedures take place on the day prior to abortion.

On the day of the abortion, 1 hour prior to the procedure, the following study procedures will be conducted. Women will be given the study medication, which consists of two tablets of either misoprostol 200 mcg (400 mcg total) or placebo (folic acid 2 mg). The medication will be dispensed from opaque sequentially numbered vials so that double-blinding is maintained. The subject will be asked questions about symptoms prior to administration of the study medication. She will then hold the medication buccally (in her cheek) for 20 minutes and then swallow any remaining tablet. Immediately prior to the abortion, the subject will be asked about her symptoms again.

The abortion will commence 1 hour after administration of the study medication. The following study procedure will be done at the start of the abortion. The amount of cervical dilation will be measured by cervical dilators, starting with the largest dilator and progressively using smaller dilators until the largest one that will pass is determined. This generally takes less than 30 seconds.

The abortion will then be done with a combination of suction and extraction, which is part of standard clinical care at BMC. The following research procedures will be conducted: the length of the procedure will be recorded, and the woman will be asked afterward about her pain level during the abortion. This concludes the study procedures for the woman. Her time in the study is one day.

After the abortion, the fetus and placenta will be removed from the collected specimen and weighed and sent to pathology as per usual clinical procedure. The following study procedure will be done. The collected fluid from the suction machine, consisting of blood and amniotic fluid, will be measured. If the drapes or towels have been soiled with blood or fluid, they will be weighed and the amount added to the total measured from the suction machine. The amount of blood will be calculated by comparison with the expected amount of amniotic fluid as published by Hern (attached in Section S). Note that the amount of fetal blood is very small, less than 20 ml at the highest gestational age in this study, and will not appreciably change the total. If all of the blood and fluid has been collected into the suction jar (and none of the towels are soiled), then 5 ml of the mixed fluid will be sent for a hemoglobin level, and the percentage of blood calculated from that, as pure amniotic fluid will have a hemoglobin level of zero. This results will be used for confirmation when available, but will not be used as the primary outcome. Measurements on the fluid will be completed on the day of abortion. The fluid is normally discarded and will be discarded after measures are complete.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol; 400 mcg buccally 2 hours prior to procedure	Drug: Misoprostol; 400 mcg buccally 2 hours prior to procedure; Other Names: Cytotec
Placebo Comparator: Placebo (Folic acid); Two 1-mg tablets buccally 2 hours prior to procedure	Other: Folic acid; 2mg buccally 2 hours prior to procedure; Other Names: Vitamin B9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	500 cc or more	one day following the procedure

Collaborators and Investigators

• Sponsor: Boston University
• Investigators: Principal Investigator: Sarita Sonalkar, MD, Boston Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: April 18, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Micronutrients; Vitamins; Reproductive Control Agents; Anti-Ulcer Agents; Vitamin B Complex; Hematinics; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol; Folic Acid
• Other Study ID Numbers: H-30452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No