Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage

October 19, 2020 updated by: Dr.Dalia Mohammed Al Sayed Zaki

Study at Zagazig General Hospital

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?

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Sharqia
      • Zagazig, Sharqia, Egypt, 1436
        • Dalia Mohammed Al Sayed Zaki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete abortion
Time Frame: 1week
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
1week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr.Dalia Mohammed Al Sayed Zaki

Collaborators

Benha University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

October 1, 2020

Study Completion (Anticipated)

November 15, 2020

Study Registration Dates

First Submitted

October 13, 2020

First Submitted That Met QC Criteria

October 13, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treatment of missedmiscarriage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Study Data/Documents

  1. Individual Participant Data Set
    Information comments:

    Albrecht ED, Aberdeen GW, Pepe GJ, (2000). The role of estrogen in the maintenance of primate pregnancy. Am J Obstet Gynecol. 182:432-8.

    Albrecht ED, Robb VA, Pepe GJ, (2004). Regulation of placental vascular endothelial growth permeability factor expression and angiogenesis by estrogen during early baboon pregnancy. J Clin Endocrinol Metab. 89:

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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