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Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage

Sponsor
Dr.Dalia Mohammed Al Sayed Zaki (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04593108
Collaborator
Benha University (Other)
320
Enrollment
1
Location
22
Anticipated Duration (Months)
14.5
Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase
  • Device: Letrozole misoprostol
  • Drug: Misoprostol, placebo

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
320 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Study at Zagazig General Hospital
Actual Study Start Date :
Jan 15, 2019
Actual Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Nov 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Letrozole misoprostol

Group (A): A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start

Device: Letrozole misoprostol
Letrozole give pretreatment of abortion by misoprostol
Misoprostol,placebo

Group (B): A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start

Drug: Misoprostol, placebo
Give placebo pretreatment of abortion by misoprostol

Outcome Measures

Primary Outcome Measures

  1. Complete abortion [1week]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dalia Mohammed Al Sayed Zaki Zagazig Sharqia Egypt 1436

Sponsors and Collaborators

  • Dr.Dalia Mohammed Al Sayed Zaki
  • Benha University

Investigators

  • Principal Investigator: Zagazig General hospital, Ministry hospital, Zagazig general hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Dr.Dalia Mohammed Al Sayed Zaki, Banha university, Benha University
ClinicalTrials.gov Identifier:
NCT04593108
Other Study ID Numbers:
  • Treatment of missedmiscarriage
First Posted:
Oct 19, 2020
Last Update Posted:
Oct 20, 2020
Last Verified:
Oct 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Abortion, Missed
Letrozole
Misoprostol

Study Results

No Results Posted as of Oct 20, 2020