Clinical trial NCT02405156: Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
Official title: A Prospective Double-Blind, Randomized, Placebo-Controlled Trial on the Use of Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Miscarriage
Keywords: Letrozole
misoprostol
second trimester miscarriage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.

Detailed description: This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.

Patients fulfilling inclusion and exclusion criteria will be divided into two groups.

Group (A):

181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.

Group (B):

181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.

Data recording:

1. Duration of complete abortion.
2. Post abortion bleeding.
3. Incomplete delivery of the placenta necessitates evacuation under anesthesia.
4. Hemoglobin and hematocrit after 24 hours from abortion to estimate the decrease in hemoglobin level.
5. Recording maternal morbidities.
6. Patients that will receive 5 doses and did not abort till 24 hours from the first dose of misoprostol will be considered failed induction and will stop follow up without reporting outcome.

Eligibility criteria: Inclusion Criteria:

* Maternal age more than 18 years old (age of legal consent).
* Gestational age between 12 weeks and 24 weeks.
* Hemoglobin \>10 g/dL.
* BMI between 25 kg/m2 and 35 kg/m2.
* Miscarriage .
* Living fetus with multiple congenital malformations incompatible with life.
* PPROMs with drained liquor and parents are consenting for termination of pregnancy.

Exclusion Criteria:

* Maternal age less than 18 years old.
* Gestational age less than 12 weeks or more than 24 weeks.
* Hemoglobin \<10 g/dL.
* Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).
* Polyhydraminos.
* Anencephaly.
* Fibroid uterus.
* BMI less than 25kg/m2 and more than 35kg/m2.
* Coagulopathy.
* History or evidence of adrenal pathology.
* Previous attempts for induction of abortion in the current pregnancy.

Primary outcomes:
measure: Duration of induction of abortion
timeFrame: 24 hours
Secondary outcomes:
measure: The incidence of need for surgical evacuation of placenta.
timeFrame: 24 hours
measure: Hemoglobin change
timeFrame: 24 hours
measure: Maternal morbidity
timeFrame: 24 hours
measure: Success of induction of abortion
timeFrame: 24 hours
measure: Hematocrit change
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Mostafa Gomaa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Ihab Serag-ElDin, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Gasser El-Bishry, FRCOG
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Ahmed Swidan, M.B.B.ch
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Mohamed S. Sweed, MD
role: PRINCIPAL_INVESTIGATOR
References: