Miscarriage in First Trimester, Missed Miscarriage
Conditions
Keywords
Abortion, missed, Abortion, induced, Letrozole, Misoprostol, first trimester
Brief summary
The goal of this clinical trial is to learn whether adding the medicine letrozole to Misoprostol helps women have a complete abortion more often than using Misoprostol alone for the treatment of missed miscarriage (when a pregnancy has stopped developing but has not yet passed naturally). The main questions this study aims to answer are: 1. Does taking letrozole for 3 days before misoprostol increase the chance of a complete abortion compared to misoprostol alone? 2. Does the use of letrozole affect the time it takes for abortion to occur? Who can Join? i. Women up to 13 weeks of pregnancy (based on last menstrual period and confirmed by ultrasound) who have a missed miscarriage. ii. Only those with a single pregnancy are eligible. iii. Women with a previous cesarean section or uterine scar are not included. What Will Happen in the Study A total of 92 women will take part. Participants will be randomly assigned to one of two groups: Group A: Letrozole tablets once daily for 3 days, followed by one dose of vaginal misoprostol. Group B: Placebo tablets for maximum of 3 days, followed by one dose of vaginal misoprostol. Doctors will monitor whether the abortion is complete within 24 hours. If it is not, other medical procedures will be offered as needed. Products of conception will be examined to confirm abortion.
Interventions
800 micrograms of a single dose of vaginal misoprostol will be given
DRUGLetrozole 5 mg
10 mg oral letrozole for 3 days will be given
DRUGPlacebo
oral placebo for three days will be given
Sponsors
Nishtar Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Pregnant women up till 13th weeks of gestation according to last menstrual period (LMP) dates, confirmed on ultrasound * Single intrauterine pregnancy * Planned for termination due to missed miscarriage
Exclusion criteria
* Previous history of cesarean section * Uterine scar due to previous procedure like myomectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete abortion | From start of study medication after randomization to within 24-hours | The expulsion of both fetus and placenta without operative intervention and no retained products of conception confirmed on ultrasound. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Induction-abortion interval | From start of study medication to abortion, within 24-hours | The time interval (in hours) from the administration of first dose of Misoprostol up to the time when the fetus aborted. |
Countries
Pakistan
Contacts
Primary ContactAfrayshum T Principal Investigator, MBBS
Outcome results
None listed