MMSAP: Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation

• Sponsor: Medstar Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02412618
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Duration (Months): 16

Study Details

Study Description

Brief Summary

A randomized double---blinded comparison of same---day mifepristone and misoprostol with misoprostol only for cervical preparation in second---trimester surgical abortion in 100 women at 14 0/7---19 6/7 weeks gestation.

Condition or Disease	Intervention/Treatment	Phase
Induced Abortion	Drug: Mifepristone; Drug: Misoprostol; Dietary Supplement: Placebo	Phase 4

Detailed Description

Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6 hours prior to D&E. Primary outcome was cervical dilation assessed by the largest Hegar dilator accepted without resistance. Secondary outcomes included total procedure time, and patient and provider perceptions. The study was powered to detect a 2-mm difference in cervical dilatation with 48 participants in each arm.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Comparison of Same-Day Oral Mifepristone-Misoprostol to Misoprostol Only for Cervical Preparation in Second Trimester Surgical Abortion
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mifepristone Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once	Drug: Mifepristone; Progesterone antagonist; Other Names: Mifeprex ; Drug: Misoprostol; Prostaglandin E1; Other Names: Cytotec
Placebo Comparator: Placebo Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once	Drug: Misoprostol; Prostaglandin E1; Other Names: Cytotec ; Dietary Supplement: Placebo; Tasteless, odorless, sugar based pill

Outcome Measures

Primary Outcome Measures

1. Initial Cervical Dilation [Assessed 4-6 hour following medications at time of D&E procedure]

   Initial cervical dilation as measured by Hegar Dilator accepted with least resistance

Secondary Outcome Measures

1. Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale) [intraoperative]

   5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy women

• eligible for non---urgent D&E

• 14 0/7 weeks to 19 6/7 weeks gestation, confirmed by sonogram

Exclusion Criteria:

• emergent need for D&E

• fetal demise

• intolerance

• allergy or contraindication to mifepristone or misoprostol

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medstar Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT02412618
• Other Study ID Numbers: 2012-245
• First Posted: Apr 9, 2015
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Misoprostol; Mifepristone

Study Results

Participant Flow

Arm/Group Title	Mifepristone	Placebo
Arm/Group Description	Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1
Period Title: Overall Study
STARTED	50	50
COMPLETED	48	48
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Mifepristone	Placebo	Total
Arm/Group Description	Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Misoprostol: Prostaglandin E1 Placebo: Tasteless, odorless, sugar based pill	Total of all reporting groups
Overall Participants	50	50	100
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	50 100%	50 100%	100 100%
>=65 years	0 0%	0 0%	0 0%
Sex/Gender, Customized (Number) [Number]
Female	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

Title	Initial Cervical Dilation
Description	Initial cervical dilation as measured by Hegar Dilator accepted with least resistance
Time Frame	Assessed 4-6 hour following medications at time of D&E procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mifepristone	Placebo
Arm/Group Description	Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1
Measure Participants	48	48
Mean (95% Confidence Interval) [mm]	11.7	10.9

2. Secondary Outcome

Title	Patient Acceptability and Assessment of Pain and Side Effects (5-point Likert Scale)
Description	5-point Likert scale given to patients following procedure once recovered from anesthesia assessing pain, side effects including nausea, vomiting, diarrhea, cramping, and if they would choose the method again or recommend to friends. Likert scale: Strongly agree (5), Agree (4), Neutral (3), Disagree (2), Strongly Disagree (1)
Time Frame	intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mifepristone	Placebo
Arm/Group Description	Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1	Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1
Measure Participants	48	48
Nausea	4	4
Severe Cramps	4	4

Adverse Events

Arm/Group Title	Placebo		Mifepristone
Arm/Group Description	Placebo oral tablets, odorless, colorless and matched to Mifepristone appearance Misoprostol 400 mcg tablets, vaginally, once Placebo: Tasteless, odorless, sugar based pill Misoprostol: Prostaglandin E1		Mifepristone 200mg oral tablet, once Misoprostol 400 mcg tablets, vaginally, once Mifepristone: Progesterone antagonist Misoprostol: Prostaglandin E1
All Cause Mortality
	Placebo		Mifepristone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Serious Adverse Events
	Placebo		Mifepristone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Mifepristone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.