Sublingual vs Vaginal Misoprostol for Termination of First Trimesteric Missed Abortion

NCT ID: NCT05001061

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-03

Study Completion Date

2021-10-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Missed Abortion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Misoprostol Pill

Intervention Type DRUG

sublingual versus vaginal Misoprostol in termination of first trimester missed abortion

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

Group Type ACTIVE_COMPARATOR

Misoprostol Pill

Intervention Type DRUG

sublingual versus vaginal Misoprostol in termination of first trimester missed abortion

Interventions

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Misoprostol Pill

sublingual versus vaginal Misoprostol in termination of first trimester missed abortion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients refused the medical treatment.
* Patients have contraindications of the drug (Misoprostol).
* Missed abortion associated with any signs of sepsis
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahmoud Emam Ahmed

Resident in obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmed Emam

Role: CONTACT

01003304781

References

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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.

Reference Type BACKGROUND
PMID: 32700359 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17963768 (View on PubMed)

Other Identifiers

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Misoprostol abortion

Identifier Type: -

Identifier Source: org_study_id

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