Back to results

Medical Abortion for Emergency Contraception Failure

Primary Purpose

Emergency Contraception, Abortion, Induced

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

mifepristone combined misoprostol

misoprostol alone protocol

About this trial

This is an interventional treatment trial for Emergency Contraception focused on measuring Medical abortion, emergency contraception, mifepristone

Eligibility Criteria

16 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Participants included in the study were women aged 16 years or older
with good general health,
experiencing a mifepristone emergency contraception failure,
presenting an intrauterine singleton pregnancy confirmed by pelvic ultrasound scan, with a crown-rump length compatible within 56 days of gestation at the enrolled day, and
seeking a medical abortion for unwanted pregnancy.
Women who had a threatened abortion or a failure pregnancy were also included.
Participants were required to sign an informed consent form before enrolment, willing to comply with the schedule of follow-up visits and willing to undergo surgical aspiration if indicated.

Exclusion Criteria:

The exclusion criteria included suspected or proven ectopic pregnancy,
allergy or contraindications for mifepristone (chronic systemic corticosteroid therapy, adrenal insufficiency) or misoprostol (hypertension, mitral stenosis, severe asthma, glaucoma, sickle cell anemia and hypotension),
history or evidence of thromboembolism, cardiovascular disease or liver disease, hemoglobin ≤ 90 g/l, heavy smoking (more than 10 per day),
presence of an intrauterine device, and breastfeeding.
Other exclusion criteria included participants who had EC failure because incorrect use, for example, having further unprotected intercourse after EC.

Sites / Locations

Taizhou Hospital of zhejiang Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Mf+Ms

Ms-alone

Arm Description

The women in mifepristone combined misoprostol group (Mf+Ms) received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally

The control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3.

Outcomes

Primary Outcome Measures

complete abortion rate

Secondary Outcome Measures

side effects, timing of expulsion and duration of bleeding

Full Information

NCT ID

NCT00677755

First Posted

May 7, 2008

Last Updated

May 15, 2008

Sponsor

Taizhou Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00677755

Brief Title

Medical Abortion for Emergency Contraception Failure

Official Title

Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Taizhou Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.

Detailed Description

Women usually request an abortion when they have experienced an emergency contraception (EC) failure; this population represents 13% of all early pregnancy terminations in China. Many women would prefer to choose a medical abortion in order to avoid anesthesia, over a surgical operation. However, medical termination of a pregnancy after mifepristone EC failure has not been studied although it has already been extensively practiced by empirical means in China. There is no clarification in literature as to whether mifepristone is still effective in medical abortion with its previous failure experience in EC. This randomized study was aimed to compare the efficacy, safety and acceptability of pre-treatment with mifepristone and misoprostol compared to misoprostol alone in the medical termination of pregnancy by mifepristone EC failure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Emergency Contraception, Abortion, Induced

Keywords

Medical abortion, emergency contraception, mifepristone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

394 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mf+Ms

Arm Type

Experimental

Arm Description

Arm Title

Ms-alone

Arm Type

Experimental

Arm Description

The control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3.

Intervention Type

Drug

Intervention Name(s)

mifepristone combined misoprostol

Intervention Description

women received a single dose of mifepristone (Mifepristone tablets; Xianju Pharmacy, Zhejiang, China) 200mg orally on day 1, and then returned to the clinic on day 3 and were given misoprostol (Cytotec tables; Searle,A Division of Monsanto.P.L.C, England )0.8mg orally

Intervention Type

Drug

Intervention Name(s)

misoprostol alone protocol

Intervention Description

patients were only administered 0.8 mg of misoprostol orally on day 3.

Primary Outcome Measure Information:

Title

complete abortion rate

Time Frame

study day 17 (14 days after misoprostol)

Secondary Outcome Measure Information:

Title

side effects, timing of expulsion and duration of bleeding

Time Frame

timing of expulsion at day 17, others at 45day after abortion

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Participants included in the study were women aged 16 years or older with good general health, experiencing a mifepristone emergency contraception failure, presenting an intrauterine singleton pregnancy confirmed by pelvic ultrasound scan, with a crown-rump length compatible within 56 days of gestation at the enrolled day, and seeking a medical abortion for unwanted pregnancy. Women who had a threatened abortion or a failure pregnancy were also included. Participants were required to sign an informed consent form before enrolment, willing to comply with the schedule of follow-up visits and willing to undergo surgical aspiration if indicated. Exclusion Criteria: The exclusion criteria included suspected or proven ectopic pregnancy, allergy or contraindications for mifepristone (chronic systemic corticosteroid therapy, adrenal insufficiency) or misoprostol (hypertension, mitral stenosis, severe asthma, glaucoma, sickle cell anemia and hypotension), history or evidence of thromboembolism, cardiovascular disease or liver disease, hemoglobin ≤ 90 g/l, heavy smoking (more than 10 per day), presence of an intrauterine device, and breastfeeding. Other exclusion criteria included participants who had EC failure because incorrect use, for example, having further unprotected intercourse after EC.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

YiYang Zhu, MD

Organizational Affiliation

Centra for Reproductive Medicine of Taizhou hospital

Official's Role

Study Director

Facility Information:

Facility Name

Taizhou Hospital of zhejiang Province

City

Taizhou City

State/Province

Zhejiang

ZIP/Postal Code

317000

Country

China

12. IPD Sharing Statement

Learn more about this trial

Medical Abortion for Emergency Contraception Failure

We'll reach out to this number within 24 hrs