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Completed

NCT Number: NCT00677755

Medical Abortion for Emergency Contraception Failure

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.

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Key information

Age range

16 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Taizhou Hospital of zhejiang Province

Taizhou, Zhejiang, 317000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mifepristone combined misoprostol

Drug

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

misoprostol alone protocol

Drug

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

Primary outcomes

  1. complete abortion rate

    Time frame: study day 17 (14 days after misoprostol)

Secondary outcomes

  1. side effects, timing of expulsion and duration of bleeding

    Time frame: timing of expulsion at day 17, others at 45day after abortion

Sponsors and collaborators

Lead sponsor

Taizhou Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
May 14, 2008
Registry last updated
May 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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