TWO DOSES OF MIFEPRISTONE FOLLOWED BY MISOPROSTOL FOR MEDICAL TERMINATION OF PREGNANCY IN THE SECOND TRIMESTER

Phase 4

Registration Number: CTRI/2017/12/010862

Lead Sponsor: PGIMER

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

A total number of 100 women admitted for MTP in 2nd trimester (13-20 weeks) will be recruited provided they fulfil the following inclusion and exclusion criteria:

Inclusion Criteria:

1.Age >=18 yrs to 45 years and a singleton intrauterine viable pregnancy

2.Gestational age 13-20 weeks

3.Women fulfilling the pre-requisites of Indian MTP Act, 1972

Exclusion Criteria

Exclusion Criteria:

1.Having either taken MTP Pill from outside or self prescribed or incomplete abortion

2.Prior two or more uterine surgeries (caesarean / myomectomy)

3.Moderate or severe anaemia (Haemoglobin <8 gm /dL)

4.Heart disease, uncontrolled hypertension ( >140/90 mm hg) bronchial asthma, coagulation disorder and any other medical illness

5.Known hypersensitivity to mifepristone or misoprostol

6.Haemodynamically unstable at the time of presentation

7.Contra-indications to the use of mifepristone or misoprostol: ectopic pregnancy, inherited porphyria, chronic adrenal failure, on immunosuppressants (corticosteroids).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objective: <br/ ><br>To calculate the induction abortion interval (IAI) in women undergoing second trimester (13-20 weeks) MTP using two doses of oral mifepristone, 200 mg tablet, given 24 hours apart followed by misoprostol. <br/ ><br>Timepoint: 72 hours <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Secondary objectives: <br/ ><br>1.Success of the present method for abortion without the need of any other method. <br/ ><br>2.Need of curettage after medical abortion. <br/ ><br>3.Side effects like vomiting, diarrhoea, fever and excessive blood loss needing blood transfusion <br/ ><br>Timepoint: 48 hours