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Status unknownNCT04593108Updated Oct 20, 2020

Misoprostol With or Without Letrozole in Treatment of Missed Miscarriage

An observational study in Missed Abortion, sponsored by Dr.Dalia Mohammed Al Sayed Zaki. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-20.

Sponsored by Dr.Dalia Mohammed Al Sayed Zaki · Observational

The sponsor has not verified this record recently (last verified Oct 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
320
Ages
18 Years to 35 Years
Sex
Female
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Study 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?

Read the 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.
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Conditions studied

  • Missed Abortion

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03

In context

Abortion, Missed

53 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.

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Lead sponsor

This is the only study on the registry with Dr.Dalia Mohammed Al Sayed Zaki as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
320 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • DeviceLetrozole misoprostol

    Letrozole give pretreatment of abortion by misoprostol

  • DrugMisoprostol, placebo

    Give placebo pretreatment of abortion by misoprostol

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What researchers measure

Primary outcomes

  1. Complete abortion

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

    Time frame: 1week

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Study locations

1 site
  • Dalia Mohammed Al Sayed Zaki
    Zagazig, Sharqia 1436, Egypt
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References and documents

Publications

  • Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf. PubMed 21252745 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04593108
Lead sponsor
Dr.Dalia Mohammed Al Sayed Zaki
Collaborators
Benha University
Responsible party
Dr.Dalia Mohammed Al Sayed Zaki (Banha university, Benha University) — Sponsor-investigator
First posted
Oct 19, 2020
Start date
Jan 15, 2019
Primary completion
Oct 1, 2020
Completion
Nov 15, 2020 (estimated)
Last update
Oct 20, 2020

Study contacts

Zagazig General hospital, Ministry hospital
principal investigator · Zagazig general hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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