ClinicalTrials.gg
Status unknownNCT03628625Updated Oct 9, 2018

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

A Phase 2 interventional study of Letrozole 2.5mg and Placebo in Miscarriage and Missed Abortion, sponsored by Ain Shams Maternity Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.

Primary conditionAbortion, MissedRegistry: Abortion, SpontaneousReclassifiedWhy we changed it
Registry
Abortion, Spontaneous — the first condition term the registry derived for this study.
ClinicalTrials.gg
Abortion, Missed
Why
  1. The study's listed conditions name Abortion, Missed, a narrower term within Abortion, Spontaneous.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Ain Shams Maternity Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Abortion, Missed with a site in Egypt — none open to participants now, none under way, none of them phase 3. Abortion, Missed · Egypt.

Planned enrollment
8th of 11
80 · median 140
Started
2018
with 1 other
Phase 2
3 of 12
none open now
Registered
5th of 12
by date
Lead sponsor
1 of 12
Ain Shams Maternity Hospital

Among the 12 studies in Abortion, Missed with a site in Egypt, this one is the 8th largest by planned enrollment of the 11 interventional ones, is one of 2 that started in 2018, is one of 3 in phase 2, and was the 5th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phase3 · 0 open
Phase 2this study3 · 0 open
Phase 32 · 0 open
Phase 42 · 0 open
Observational1 · 0 open
Phase 11 · 0 open

By the year they started

First in 2015; this study’s year is marked. 2 started in 2018.

Size and results

Median enrollment 140 across the 11 interventional studies, 320 across the 1 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

Was this useful?
Download CSVWith an account: the 12 studies in Abortion, Missed with a site in Egypt as a file.
02

Study summary

This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Read the 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.

03

Conditions studied

  • Miscarriage
  • Missed Abortion

Browse trials for

04

In context

Abortion, Missed Reclassified

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

This study's planned enrollment of 80 is below the median of 110 across 41 interventional studies indexed under Abortion, Missed.

Browse Abortion, Missed studies →

Lead sponsor

Ain Shams Maternity Hospital is the lead sponsor of 139 studies on the registry; 8 are open to participants now.

Compared within Abortion, Missed, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Abortion, Spontaneous. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

06

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Study group

    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.

    Drug: Letrozole 2.5mg · Drug: Misoprostol

  • Placebo comparator
    Control group

    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

    Drug: Placebo · Drug: Misoprostol

Interventions

  • total dose 7.5 mg per day for 3 days

  • DrugPlacebo

    Folic acid for 3 days

  • Misoprosrol 800mcg will be given to all patients for induction of abortion

07

What researchers measure

Primary outcomes

  1. Incidence of complete miscarriage

    Time frame: 6 hours

Secondary outcomes

  1. Need for surgical evacuation of the products of conception

    Time frame: 6 hours

  2. Incidence of Septic Abortion

    Time frame: 1 week

08

Study locations

1 of 1 sites recruiting
  • Ain Shams University, Maternity Hospital
    Cairo, Egypt
    Recruiting
    • Dina Mansour · Contact
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2018 (actual). Primary completion is estimated for Dec 2018, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 10, 2018
First posted
Aug 14, 2018
StartActual
Sep 10, 2018
Primary completionEst.
Dec 5, 2018
CompletionEst.
Dec 10, 2018
Last update
Oct 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03628625
Responsible party
Dr- dina yahia mansour (Lecturer of Obstetrics and Gynecology Ain Shams University, Ain Shams Maternity Hospital) — Principal investigator
First posted
Aug 14, 2018
Start date
Sep 10, 2018
Primary completion
Dec 5, 2018 (estimated)
Completion
Dec 10, 2018 (estimated)
Last update
Oct 9, 2018

Study contacts

Dina Mansour
Contact
Dinayahiamansour@hotmail.com
+20100657

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Letrozole

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