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A study to compare vaginal and sublingual routes of misoprostol following mifepristone for second trimester(13-20 weeks period of gestation) abortions

A Randomized study to compare vaginal and sublingual routes of misoprostol following mifepristone for second trimester medical termination of pregnancy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024818
Enrollment
120
Registered
2020-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O048- (Induced) termination of pregnancywith other and unspecified complications

Interventions

Intervention1: Tab Misoprostol: We are comparing the two routes of administration of misoprostol i.e Sublingual vs vaginal ,for second trimester medical termination of pregnancy following mifepristone

Sponsors

PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Females in above mentioned age group with singleton viable intrauterine pregnancy 2.Gestational age 13-20weeks 3.Women fulfilling the pre-requisites of Indian MTP Act, 1972

Exclusion criteria

Exclusion criteria: 1.Prior 2 or more uterine surgeries 2.Having either taken MTP pill from outside or self prescribed or with inevitable or incomplete abortion 3.Moderate or severe anaemia(Hb 4.Heart disease, uncontrolled HTN(140/90mmHg), bronchial asthma, coagulation disorder and any other medical illness 5.Known hypersenstivity to mifepristone or misoprostol 6.Hemodynamically unstable at the time of presentation 7.Contra-indications to the use of mifepristone or misoprostol like ectopic pregnancy, inherited porphyria, chronic adrenal failure , on immunosuppressants 8.Presence of vaginal discharge suggestive of vaginitis

Design outcomes

Primary

MeasureTime frame
To compare the induction abortion interval(IAI) among women undergoing second trimester MTP using two different routes of misoprostol (vaginal or sublingual) after priming with mifepristone Timepoint: From beginning of misoprostol to completion of abortion—

Secondary

MeasureTime frame
1.Complete expulsion of products of conception at 24h and 48h without the need of any other method 2.Need of curettage after medical abortion 3.Side effects like vomiting, diarrhoea, fever and excessive blood loss needing blood transfusion 4.To assess absorption of tablet misoprostol by seeing the presence of undissolved tablet remnants in vaginal group and need to swallow sublingual tablet at the end of half-hour in sublingual group Timepoint: From beginning of misoprostol to completion of abortion—

Countries

India

Contacts

Public ContactDr Rashmi Bagga

PGIMER

rashmibagga@gmail.com9872494602

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026