Emergency ContraceptionNCT00677755
Medical Abortion for Emergency Contraception Failure
A study testing mifepristone combined misoprostol and misoprostol alone protocol in people with Emergency Contraception and Abortion, Induced, run by Taizhou Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women only
- Conditions the study is for
- Emergency Contraception, Abortion, Induced
- What is being tested?
- mifepristone combined misoprostol and misoprostol alone protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- Oct 2004to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone.
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.
Read the 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.
- Conditions
- Emergency Contraception, Abortion, Induced
- Being tested
- mifepristone combined misoprostol, misoprostol alone protocol
- Keywords
- Medical abortion, emergency contraception, mifepristone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mifepristone combined misoprostolDrug
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 protocolDrug
patients were only administered 0.8 mg of misoprostol orally on day 3.
| Study group | Role | What they receive |
|---|---|---|
| Mf+Ms | Experimental | 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 Receives: Drug: mifepristone combined misoprostol |
| Ms-alone | Experimental | The control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3. Receives: Drug: misoprostol alone protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete abortion rate
Measured: study day 17 (14 days after misoprostol)
Secondary outcomes (1)
side effects, timing of expulsion and duration of bleeding
Measured: timing of expulsion at day 17, others at 45day after abortion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startOct 2004
- Primary completionSep 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Investigators
- YiYang Zhu, MD, Study director, Centra for Reproductive Medicine of Taizhou hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677755
- Sponsor's protocol ID
- Taizhou2004-08
- Status last verified
- May 2008
- First submitted
- 7 May 2008
- Last updated
- 16 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Termination of Pregnancy Due to Emergency Contraception Failure: A Randomized Trial Comparing Mifepristone Combined Misoprostol and Misoprostol Alone.
- ClinicalTrials.gov ID
- NCT00677755
- Acronym / sponsor ID
- Taizhou2004-08
- Conditions
- Emergency Contraception, Abortion, Induced
- Keywords
- Medical abortion, emergency contraception, mifepristone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mf+Ms | Experimental | Drug: mifepristone combined misoprostolThe 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 |
| Ms-alone | Experimental | Drug: misoprostol alone protocolThe control group (Ms-alone) patients were only administered 0.8 mg of misoprostol orally on day 3. |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mifepristone combined misoprostolwomen 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 | Drug | Mf+Ms |
| misoprostol alone protocolpatients were only administered 0.8 mg of misoprostol orally on day 3. | Drug | Ms-alone |
Primary outcome
complete abortion rate
Time frame: study day 17 (14 days after misoprostol)
1 secondary outcome
side effects, timing of expulsion and duration of bleeding
Time frame: timing of expulsion at day 17, others at 45day after abortion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YiYang Zhu, MD study director
Centra for Reproductive Medicine of Taizhou hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mifepristone combined misoprostol and misoprostol alone protocol in people with Emergency Contraception and Abortion, Induced, run by Taizhou Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete abortion rate (time frame: study day 17 (14 days after misoprostol)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2008.