Miscarriage
Conditions
Brief summary
Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.
Interventions
DRUGMifepristone
Participants with 1st trimester miscarriage will receive for medical termination
DRUGLetrozole
Participants with 1st trimester miscarriage will receive for medical termination
Sponsors
Calcutta National Medical College and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
: * Women older than 18years who will give consent regarding medical management of missed abortion * First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography * Hemoglobin level more than 12g/dl. To improve sample size later hemoglobin level 10 gm% or more was considered and EC was informed on 5.10.2022 about this minor change in the study design.
Exclusion criteria
: * Hemodynamically unstable patient * Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen * History or clinical evidence of any thromboembolic impairment or deep venous thrombosis * Having intra-uterine device * Present or previous use of corticosteroids * History of any malignancy * Existing cardiovascular disease contraindicating misoprostol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Expulsion of product of conception | 24 hours since administration of misoprostol | Mean duration of expulsion since administration of vaginal misoprostol |
| Requirement of surgical evacuation | beyond 24 hours since misoprostol administration | Surgical evacuation where complete abortion does not occur |
Countries
India
Outcome results
None listed