CClinicalTrials.gg
Status unknownNCT05001061Updated Aug 11, 2021

Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

An Early Phase 1 interventional study of Misoprostol Pill in Missed Abortion, sponsored by Cairo University. Status unknown. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-11.

Sponsored by Cairo University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
288
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

Efficacy of sublingual versus vaginal misoprostol in termination of first trimester missed abortion

Read the detailed description

study will be made on female patients with first trimester missed abortion confirmed by ultrasound . Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol and the other group(B) will receive vaginal Misoprostol as a 800 micro grams every 4 hours in both groups up to five doses the aim of the study is to compare efficay of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion and which route is the best will less side effects.

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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.

This study's planned enrollment of 288 is above the median of 142 across 44 interventional studies indexed under Abortion, Missed.

Browse Abortion, Missed studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women with an ultrasound diagnosis of missed abortion \< 13 weeks gestation without any clinical criteria of Inevitable abortion.

Exclusion criteria

Exclusion Criteria:

  • Patients refused the medical treatment.
  • Patients have contraindications of the drug (Misoprostol).
  • Missed abortion associated with any signs of sepsis
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
288 participants (estimated)

Study arms

  • Active comparator
    Sublingual Misoprostol for termination of first trimester missed abortion

    Patients diagnosed as first trimester missed abortion will receive sublingual Misoprostol 800 micrograms every 4 hours up to five doses

    Drug: Misoprostol Pill

  • Active comparator
    Vaginal Misoprostol for termination of first trimester missed abortion

    Patients diagnosed as first trimester missed abortion will receive vaginal Misoprostol 800 micrograms every 4 hours up to five doses

    Drug: Misoprostol Pill

Interventions

  • DrugMisoprostol Pill

    sublingual versus vaginal Misoprostol in termination of first trimester missed abortion

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What researchers measure

Primary outcomes

  1. The occurance of complete abortion within 24 hours with Misoprostol drug

    Efficacy of sublingual and vaginal Misoprostol in complete termination of first trimester missed abortion

    Time frame: Within 24 hours

  2. Which route is the best and less side effects in complete termination of first trimester missed abortion by Misoprostol drug

    Vaginal versus sublingual route of administration of Misoprostol for complete termination of first trimester missed abortion

    Time frame: within 24 hours

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Allameh Z, Goharian M, Eslamian M. Effect of misoprostol with and without letrozole on the induction of abortion for women with first-trimester missed abortion. Int J Gynaecol Obstet. 2020 Nov;151(2):214-218. doi: 10.1002/ijgo.13326. Epub 2020 Sep 1. PubMed 32700359 ↗
  • Tang OS, Gemzell-Danielsson K, Ho PC. Misoprostol: pharmacokinetic profiles, effects on the uterus and side-effects. Int J Gynaecol Obstet. 2007 Dec;99 Suppl 2:S160-7. doi: 10.1016/j.ijgo.2007.09.004. Epub 2007 Oct 26. PubMed 17963768 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2021, 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
NCT05001061
Lead sponsor
Cairo University
Responsible party
Ahmed Mahmoud Emam Ahmed (Resident in obstetrics and gynecology, Cairo University) — Principal investigator
First posted
Aug 11, 2021
Start date
Aug 3, 2021 (estimated)
Primary completion
Oct 15, 2021 (estimated)
Completion
Oct 16, 2021 (estimated)
Last update
Aug 11, 2021

Study contacts

Ahmed Emam
Contact
emam3882@gmail.com
01003304781

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 Aug 2021. You cannot join it, but the record below documents what was studied.

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