Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services

NCT ID: NCT01862991

Last Updated: 2024-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-06-30

Brief Summary

This research study investigates the use of a drug, mifepristone, given before second trimester abortion. Mifepristone is a medication that is approved for medical abortion during the first trimester. It also has been used prior to abortion in the early seconds trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also called induction abortion). This medication has effects on the uterus that may help dilate, or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy. Cervical dilation, or opening, is essential to both ease of completion of procedure and reducing complications that can occur. These complications include laceration, or tearing, of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall of the uterus) and are not expected to be increased in the study. Dilation of the cervix is usually achieved by placing thin rods (cervical dilators) through the cervix. These rods then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard method of dilation is performed at the clinic and involves the placement of cervical dilators the day before the procedure. This procedure can be uncomfortable. A prior study showed that mifepristone reduces the number of osmotic dilators that need to be placed prior to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential adjunct to cervical dilation or used alone, without dilators, as method of cervical preparation with the hopes of reducing barriers imposed by painful procedures and time in clinic and away from work/home that the current approach involving dilators requires.

Conditions

Legally Induced Abortion Without Mention of Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dilapan-Placebo

The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.

Group Type: PLACEBO_COMPARATOR

Hygroscopic cervical dilators

Intervention Type: OTHER

Dilapan-S osmotic cervical dilators inserted through the internal os.

Misoprostol

Intervention Type: DRUG

400 mcg buccal misoprostol 90 pre-op

Intra-amniotic digoxin

Intervention Type: DRUG

1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation

Dilapan-Mifepristone

The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.

Group Type: ACTIVE_COMPARATOR

Hygroscopic cervical dilators

Intervention Type: OTHER

Dilapan-S osmotic cervical dilators inserted through the internal os.

Misoprostol

Intervention Type: DRUG

400 mcg buccal misoprostol 90 pre-op

Intra-amniotic digoxin

Intervention Type: DRUG

1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation

Mifepristone

Intervention Type: DRUG

200 mcg Mifepristone orally

Mifepristone

The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.

Group Type: EXPERIMENTAL

Misoprostol

Intervention Type: DRUG

400 mcg buccal misoprostol 90 pre-op

Intra-amniotic digoxin

Intervention Type: DRUG

1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation

Mifepristone

Intervention Type: DRUG

200 mcg Mifepristone orally

Interventions

Hygroscopic cervical dilators

Dilapan-S osmotic cervical dilators inserted through the internal os.

Intervention Type: OTHER

Misoprostol

400 mcg buccal misoprostol 90 pre-op

Intervention Type: DRUG

Intra-amniotic digoxin

1mg digoxin administered intra-amniotically \~24 hours pre-op in patients that are greater than 22 weeks gestation

Intervention Type: DRUG

Mifepristone

200 mcg Mifepristone orally

Intervention Type: DRUG

Other Intervention Names

Dilapan-S; Danco; Mifeprex

Eligibility Criteria

Inclusion Criteria

• >18 years old
• Viable, Singleton pregnancy
• Voluntarily seeking abortion between 19 and 24 wks gestation
• Able to give informed consent and comply with study protocol
• Fluent in English or Spanish

Exclusion Criteria

• Allergy to misoprostol or mifepristone

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Santa Clara Valley Medical Center

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Santa Clara Valley Medical Center

San Jose, California, United States

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Other Identifiers

PF-108666

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SU-05132013-108659

Identifier Type: -

Identifier Source: org_study_id