Clinical trial NCT04593108: Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage
Official title: Study at Zagazig General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Missed Abortion
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2020-10-19
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study Settings:

This clinical trial will be conducted in department of obstetrics and gynecology at Zagazig General Hospital during the period between January 2019 and June 2019.

Study Population:

The patients will be recruited from women attending outpatient clinic of obstetrics or the emergency room of Zagazig General Hospital.

Brief summary: Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Detailed description: Aim of the Work

Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.

Hypothesis:

Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.

Research question:

Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?

Primary outcome:

Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.

Secondary outcome:

• Curettage (surgical evacuation of the products of conception)

* Incomplete abortion (retained products of conception).
* Considerable bleeding that necessitates immediate evacuation.

Eligibility criteria: Inclusion Criteria:

* Woman age more than 18 years old (age of legal consent).
* BMI ranges between 25 kg/m2 and 35 kg/m2.
* Gestational age of 63 days' gestation (or less).
* Missed abortion.
* Hemoglobin leve

Exclusion criteria:

* Woman age less than 18 years old.
* BMI less than 25 kg/m2 or more than 35 kg/m2.
* Gestational age more than 63 days' gestation.
* Molar pregnancy.
* Hemoglobin level less than 10 gm/dL.
* Fibroid uterus.
* Uterus with congenital anomalies.
* Previous attempts for induction of abortion in the current pregnancy.
* Coagulation defect i.e. coagulopathy.
* Contraindication for induction of abortion e.g. heart failure.
* Allergy to misoprostol or letrozole.

Primary outcomes:
measure: Complete abortion
timeFrame: 1week
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Dalia Mohammed Al Sayed Zaki
state: Sharqia
Study officials:
affiliation: Zagazig general hospital
name: Zagazig General hospital, Ministry hospital
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf.