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

TWO DOSES OF MIFEPRISTONE FOLLOWED BY MISOPROSTOL FOR MEDICAL TERMINATION OF PREGNANCY IN THE SECOND TRIMESTER - Two dose Mife regimen for 2nd trimester MTP

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/12/010862

Enrollment

100

Registered

2017-12-13

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

None listed

Interventions

Intervention1: Mifepristone: oral tablet, 200mg on day 1, 200mg on day 2 Control Intervention1: Mifepristone: oral tablet, 200mg on day 1

Eligibility

Inclusion criteria

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: 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 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).

Design outcomes

Primary

Measure	Time frame
Primary Objective: 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. Timepoint: 72 hours	—

Secondary

Measure	Time frame
Secondary objectives: 1.Success of the present method for abortion 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 Timepoint: 48 hours	—

Countries

India

Contacts

Public ContactDr Rashmi Bagga

Post Graduate Institute of Medical Education and Research, Chandigarh

rashmibagga@gmail.com9872494602

Outcome results