Induced AbortionPhase 4NCT00401440
Comparison of Two Regimens of Misoprostol for Second Trimester Medical Termination of Pregnancy
A Phase 4 study testing Misoprostol in people with Induced Abortion, run by Nilratan Sircar Medical College at 1 site in India.
Trial summary
The hypothesis of the study is that the induction abortion interval time will be significantly shorter in the group receiving vaginal misoprostol every six hours in comparison to the group who are receiving vaginal misoprostol every twelve hours. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Induced Abortion
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2007to Sep 2008
- Phase
- Phase 4
- 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 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Women fulfilling indications of Medical Termination Of Pregnancy Act of India
- 12-20 weeks of pregnancy
Who cannot join
- Women with previous uterine surgery
- Contraindication of misoprostol use
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Gynae & Obstetrics, Nilratan Sircar Medical College , Kolkata
Kolkata, West Bengal, 700014
About this study
Official title: Comparison of Twq Different Regimen of Vaginal Misoprostol for Nid Trimester MTP
The hypothesis of the study is that the induction abortion interval time will be significantly shorter in the group receiving vaginal misoprostol every six hours in comparison to the group who are receiving vaginal misoprostol every twelve hours.
Read the detailed description
Objectives:
Misoprostol, a prostaglandin analogue, is principally used to prevent peptic ulcer disease induced by nonsteroidal anti-inflammatory agents .It has been shown to induce second trimester abortion .However , the optimal regimen has not been determined .Studies have used doses ranging 200- 800 microgram misoprostol at interval ranging from 3-12 hours.1,2,3,4,5 In our previous study we have compared intravaginal misoprostol with extra amniotic ethacridine lactate for second trimester MTP.6 In this study we have observed that misoprostol is highly effective( success rate 95%) for second trimester MTP with minimal side effects .\& intravaginal misoprostol results in significantly shorter induction abortion interval in comparison to extra amniotic ethacridine lactate .Induction abortion interval in this study for misoprostol was 15.5 hours and the dosage of misoprostol was 400 microgram vaginally every 12 hours with a maximum of 4 doses .Success rate and induction abortion interval are the major factors of clinical importance for second trimester MTP . Our aim is to establish a dosage schedule of misoprostol which will result in high success rate in mid trimester MTP with further shortening of induction abortion interval Our study hypothesis is that using 400 microgram of vaginal misoprostol at six hour interval will result in significant shortening of induction abortion interval in comparison to 400 microgram vaginal misoprostol at 12 hour interval.
Methods - A prospective randomized comparative clinical trial will be conducted over 200 women.
Women attending the hospital for mid trimester MTP i.e. 12-20 weeks of pregnancy will be taken up for the study. Gestational age will be determined from LMP \& per abdominal findings. Ultrasonography will be done in selected women where clinical finding is unreliable . All women will be examined for vital parameters and routine hematological and urine examination will be done. Randomization will be done using a table of random numbers .A written consent for inclusion in the study will be taken from all patients who will be included in the study.
In one group women will receive 400 microgram vaginal misoprostol tablet at interval of 12 hours with a maximum of four doses.
In other group women will receive 400 microgram vaginal misoprostol tablet at an interval of 6 hours with a maximum of four doses.
Failure of procedure in both groups will be defined as failed expulsion of fetus at 48 hours or as the occurrence of systemic adverse signs and symptoms severe enough to preclude the use of additional drugs.
The patient's vital signs will be monitored every four hours and the occurrence of signs and symptoms, such as fever, pain, vomiting, and diarrhea will be recorded. After expulsion of the fetus and placenta, check curettage will be done in every case. Completeness of abortion will be defined as expulsion of both placenta and fetus without operative assistance. The induction abortion interval will be defined as time from administration of 1st dose of Misoprostol to abortion of fetus. Hemorrhage will be defined as an estimated blood loss exceeding 500 ml or need to blood transfusion. Fever will be defined as rise of temperature 100.4˚ F or more occurring 24 hours or more after pregnancy termination.
The following parameters will be studied (1) Induction abortion interval (2) Completeness of procedure (3) Failure of abortion (4) side effects (5) cost per procedure.
Statistical analysis will be carried out with Epi Info statistical software.
- Conditions
- Induced Abortion
- Being tested
- Misoprostol
- Keywords
- Medical termination of pregnancy, Induction of abortion, Misoprostol, MTP in second trimester, 400 microgram vaginal misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses
MisoprostolDrug
400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses Receives: Drug: Misoprostol |
| B | Active comparator | 400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction abortion interval
Measured: 48 hours
Secondary outcomes (3)
Success rate
Measured: 48 hours
Side effects
Measured: 48 hours
complete expulsion of products of conception
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2006 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induced AbortionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nilratan Sircar Medical College
- Sponsor type
- Other government
- Investigators
- Snehamay Chaudhuri, MBBS,MD,DNB, Principal investigator, Nilratan Sircar Medical College , 138,AJC Bose Road , Kolkata,700014,West Bengal , India.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00401440
- Sponsor's protocol ID
- 3-Chaudhuri
- Status last verified
- Dec 2008
- First submitted
- 16 Nov 2006
- Last updated
- 12 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Twq Different Regimen of Vaginal Misoprostol for Nid Trimester MTP
- ClinicalTrials.gov ID
- NCT00401440
- Acronym / sponsor ID
- 3-Chaudhuri
- Conditions
- Induced Abortion
- Keywords
- Medical termination of pregnancy, Induction of abortion, Misoprostol, MTP in second trimester, 400 microgram vaginal misoprostol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Nilratan Sircar Medical CollegeOther government
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 20 Nov 2006 (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 hypothesis of the study is that the induction abortion interval time will be significantly shorter in the group receiving vaginal misoprostol every six hours in comparison to the group who are receiving vaginal misoprostol every twelve hours.
Detailed description
Objectives:
Misoprostol, a prostaglandin analogue, is principally used to prevent peptic ulcer disease induced by nonsteroidal anti-inflammatory agents .It has been shown to induce second trimester abortion .However , the optimal regimen has not been determined .Studies have used doses ranging 200- 800 microgram misoprostol at interval ranging from 3-12 hours.1,2,3,4,5 In our previous study we have compared intravaginal misoprostol with extra amniotic ethacridine lactate for second trimester MTP.6 In this study we have observed that misoprostol is highly effective( success rate 95%) for second trimester MTP with minimal side effects .\& intravaginal misoprostol results in significantly shorter induction abortion interval in comparison to extra amniotic ethacridine lactate .Induction abortion interval in this study for misoprostol was 15.5 hours and the dosage of misoprostol was 400 microgram vaginally every 12 hours with a maximum of 4 doses .Success rate and induction abortion interval are the major factors of clinical importance for second trimester MTP . Our aim is to establish a dosage schedule of misoprostol which will result in high success rate in mid trimester MTP with further shortening of induction abortion interval Our study hypothesis is that using 400 microgram of vaginal misoprostol at six hour interval will result in significant shortening of induction abortion interval in comparison to 400 microgram vaginal misoprostol at 12 hour interval.
Methods - A prospective randomized comparative clinical trial will be conducted over 200 women.
Women attending the hospital for mid trimester MTP i.e. 12-20 weeks of pregnancy will be taken up for the study. Gestational age will be determined from LMP \& per abdominal findings. Ultrasonography will be done in selected women where clinical finding is unreliable . All women will be examined for vital parameters and routine hematological and urine examination will be done. Randomization will be done using a table of random numbers .A written consent for inclusion in the study will be taken from all patients who will be included in the study.
In one group women will receive 400 microgram vaginal misoprostol tablet at interval of 12 hours with a maximum of four doses.
In other group women will receive 400 microgram vaginal misoprostol tablet at an interval of 6 hours with a maximum of four doses.
Failure of procedure in both groups will be defined as failed expulsion of fetus at 48 hours or as the occurrence of systemic adverse signs and symptoms severe enough to preclude the use of additional drugs.
The patient's vital signs will be monitored every four hours and the occurrence of signs and symptoms, such as fever, pain, vomiting, and diarrhea will be recorded. After expulsion of the fetus and placenta, check curettage will be done in every case. Completeness of abortion will be defined as expulsion of both placenta and fetus without operative assistance. The induction abortion interval will be defined as time from administration of 1st dose of Misoprostol to abortion of fetus. Hemorrhage will be defined as an estimated blood loss exceeding 500 ml or need to blood transfusion. Fever will be defined as rise of temperature 100.4˚ F or more occurring 24 hours or more after pregnancy termination.
The following parameters will be studied (1) Induction abortion interval (2) Completeness of procedure (3) Failure of abortion (4) side effects (5) cost per procedure.
Statistical analysis will be carried out with Epi Info statistical software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Misoprostol400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses |
| B | Active comparator | Drug: Misoprostol400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Women fulfilling indications of Medical Termination Of Pregnancy Act of India
- 12-20 weeks of pregnancy
Key exclusion criteria (2 listed)
- Women with previous uterine surgery
- Contraindication of misoprostol use
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 |
|---|---|---|
| Misoprostol400 microgram vaginal misoprostol tablet will be applied every 6 hours with a maximum of 4 doses | Drug | A |
| Misoprostol400 microgram vaginal misoprostol tablet will be applied every 12 hours with a maximum of 4 doses | Drug | B |
Primary outcome
induction abortion interval
Time frame: 48 hours
3 secondary outcomes
Success rate
Time frame: 48 hours
Side effects
Time frame: 48 hours
complete expulsion of products of conception
Time frame: 72 hours
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 12 Mar 2010.
- A comparison of intra vaginal misoprostol with extra amniotic ethacridine lactate for second trimester MTP, J Obstet Gynecol India .56.6:2006.518-521Link provided by the sponsor.
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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.
Snehamay Chaudhuri, MBBS,MD,DNB principal investigator
Nilratan Sircar Medical College , 138,AJC Bose Road , Kolkata,700014,West Bengal , India.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Induced Abortion, run by Nilratan Sircar Medical College at 1 site in India.
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 2 inclusion and 2 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 12 Mar 2010. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
induction abortion interval (time frame: 48 hours). 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 12 Mar 2010.