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Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

Primary Purpose

Miscarriage, Missed Abortion

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Letrozole 2.5mg
Placebo
Misoprostol
Sponsored by
Ain Shams Maternity Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Miscarriage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Gestational age less than 64 days gestation (<9 wks).
  • Hemoglobin >10 g/dL.
  • BMI between 18.5 kg/m2 and 25 kg/m2.
  • Missed abortion.

Exclusion Criteria:

  • Molar pregnancy.
  • Fibroid uterus.
  • Uterine anomalies.
  • Coagulopathy.
  • Medical disorder that contraindicate induction of abortion (e.g. heart failure).
  • Previous attempts for induction of abortion in the current pregnancy.
  • Allergy to misoprostol or letrozole.

Sites / Locations

  • Ain Shams University, Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.

three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses

Outcomes

Primary Outcome Measures

Incidence of complete miscarriage

Secondary Outcome Measures

Need for surgical evacuation of the products of conception
Incidence of Septic Abortion

Full Information

First Posted
May 10, 2018
Last Updated
October 5, 2018
Sponsor
Ain Shams Maternity Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03628625
Brief Title
Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage
Official Title
Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
December 5, 2018 (Anticipated)
Study Completion Date
December 10, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams Maternity Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
Detailed Description
According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week letrozole administration with misoprostol raises the rate of complete abortion Hypothesis: In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Miscarriage, Missed Abortion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses
Intervention Type
Drug
Intervention Name(s)
Letrozole 2.5mg
Intervention Description
total dose 7.5 mg per day for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Folic acid for 3 days
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Misoprosrol 800mcg will be given to all patients for induction of abortion
Primary Outcome Measure Information:
Title
Incidence of complete miscarriage
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Need for surgical evacuation of the products of conception
Time Frame
6 hours
Title
Incidence of Septic Abortion
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gestational age less than 64 days gestation (<9 wks). Hemoglobin >10 g/dL. BMI between 18.5 kg/m2 and 25 kg/m2. Missed abortion. Exclusion Criteria: Molar pregnancy. Fibroid uterus. Uterine anomalies. Coagulopathy. Medical disorder that contraindicate induction of abortion (e.g. heart failure). Previous attempts for induction of abortion in the current pregnancy. Allergy to misoprostol or letrozole.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Mansour
Phone
+20100657
Email
Dinayahiamansour@hotmail.com
Facility Information:
Facility Name
Ain Shams University, Maternity Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dina Mansour

12. IPD Sharing Statement

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Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

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