Letrozole Pretreatment With Misoprostol for Second-Trimester Medical Abortion

NCT02405156 | Completed Phase 2

• 1 other identifier: 305172
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Miscarriage

Keywords

Letrozole; misoprostol; second trimester miscarriage

Outcome Measures

Primary Outcomes (1)

• Duration of induction of abortion

  24 hours

Secondary Outcomes (5)

• The incidence of need for surgical evacuation of placenta.

  24 hours

• Hemoglobin change

  24 hours

• Maternal morbidity

  24 hours

• Success of induction of abortion

  24 hours

• Hematocrit change

  24 hours

Study Arms (2)

letrozole + misoprostol

EXPERIMENTAL

Women will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.

Drug: Letrozole; Drug: Misoprostol

placebo + misoprostol

PLACEBO COMPARATOR

Women will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses.

Drug: Placebo; Drug: Misoprostol

Interventions

Letrozole DRUG

Also known as: femara

letrozole + misoprostol

Placebo DRUG

placebo + misoprostol

Misoprostol DRUG

letrozole + misoprostol; placebo + misoprostol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Letrozole; Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Mostafa Gomaa, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Ihab Serag-ElDin, MD

  Ain Shams University

  STUDY DIRECTOR

• Gasser El-Bishry, FRCOG

  Ain Shams University

  STUDY DIRECTOR

• Ahmed Swidan, M.B.B.ch

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Mohamed S. Sweed, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohamed Samir Sweed

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: April 1, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Locations

EG (1)