Comparison of single dose and s double dose of mifepristone followed by misoprostol for termination of pregnancy in second trimester

Comparison of single dose versus double dose of mifepristone followed by misoprostol for termination of pregnancy in second trimester- A Randomised controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/04/024862

Enrollment

160

Registered

2020-04-27

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 Health Condition 2: O048- (Induced) termination of pregnancywith other and unspecified complications

Interventions

Intervention1: DOUBLE DOSE OF MIFEPRISTONE(200MG) IN SECOND TRIMESTER ABORTION ON DAY1 AND DAY2: GROUP B WILL RECEIVE DOUBLE DOSE OF MIFEPRISTONE(200MG) IN SECOND TRIMESTER ABORTION ON DAY1 AND DAY2.

Eligibility

Inclusion criteria

Inclusion criteria: singleton intrauterine viable pregnancy Gestational age 13-20 weeks Women fulfilling the pre-requisites of Indian MTP Act, 1972

Exclusion criteria

Exclusion criteria: 1.Prior two or more uterine surgeries (caesarean section or myomectomy) 2. Having either taken MTP Pill from outside or self prescribed 3. With inevitable or incomplete abortion 4. Moderate or severe anaemia (Haemoglobin 5 .Heart disease, uncontrolled hypertension ( >140/90 mm Hg), diabetes mellitus, bronchial asthma, coagulation disorder and any other medical illness 6 .Known hypersensitivity to mifepristone or misoprostol 7.Haemodynamically unstable at the time of presentation 8.Contra-indications to mifepristone or misoprostol: ectopic pregnancy, inherited porphyria, chronic adrenal failure, on immunosuppressants (corticosteroids).

Design outcomes

Primary

Measure	Time frame
Comparison of induction abortion interval between the two groups -defined as time from first dose of misoprostol to expulsion of fetus and placenta.Timepoint: The women will be kept admitted overnight or for 12 hours after the abortion.	—

Secondary

Measure	Time frame
Success rate- percentage of abortions within 24 hours after first dose of misoprostol Comparison of need for surgical intervention between two groups â?? defined as need for check curettage for retained products. Comparison of side-effects i.e. vomiting, diarrhea, fever and any complications between the two groups. Timepoint: The women will be kept admitted overnight or for 12 hours after the abortion.	—

Measure

Time frame

Success rate- percentage of abortions within 24 hours after first dose of misoprostol Comparison of need for surgical intervention between two groups â?? defined as need for check curettage for retained products. Comparison of side-effects i.e. vomiting, diarrhea, fever and any complications between the two groups. Timepoint: The women will be kept admitted overnight or for 12 hours after the abortion.

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Countries

India

Contacts

Public ContactDR VATSLA DADHWAL

AIIMS

vatslad@hotmail.com9811015979

Outcome results

None listed

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