Vaginal Progesterone for Treatment of Threatened Miscarriage

NCT ID: NCT02690129

Last Updated: 2016-02-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to assess the efficacy of vaginal micronized progesterone in the treatment of threatened miscarriage. All eligible pregnant women will be randomized to either receive vaginal progesterone or no treatment.Evaluation will be two weeks after intervention, then every 4 weeks up to 28 weeks gestation or termination of pregnancy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Threatened Miscarriage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I (Progesterone Group)

Complete bed rest as an in/or out- patient, according to patient's preference for first 48-72 hours.

* Vaginal progesterone treatment as single daily dose of natural micronized progesterone (Prontogest ® 200 mg) at bedtime for 15 days.
* If needed, a pain killer as Indomethacin 50 mg/ rectally twice daily up to control of uterine colic .
* Complete abstaining from sexual activity or strenuous effort. Additionally, Rh-ve women with established viable fetuses and continue bleeding will be given a shot of anti-D immunoglobulin 300 ugm/IM ; after 12 weeks' gestation or if undergo surgical evacuation.

Group Type ACTIVE_COMPARATOR

Vaginal Progesteron

Intervention Type DRUG

Group II ( Control group)

Will follow the same plan of management without progesterone support.

Group Type PLACEBO_COMPARATOR

Vaginal Progesteron

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vaginal Progesteron

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Progesterone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Pregnant with gestational age less than 24 weeks
2. Presented by bleeding with or without pain
3. Single viable fetus (confirmed by Ultrasound examination)
4. Accepting to have vaginal medication

Exclusion Criteria

1. Currently under medication for any chronic diseases (DM, thyroid, liver, renal, cardiac and autoimmune disease).
2. Hypersensitivity to progesterone
3. Any documented congenital fetal anomaly in the current pregnancy
4. Women received hormonal treatment in the current pregnancy
5. Patients conceived via ART
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Omar Mamdouh Shaaban

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Omar Mamdouh Shaaban

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Omar M Shaaban, MD

Role: CONTACT

+201223971457

Hany Abdel-aleem, MD

Role: CONTACT

+2088414927

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

treatment of miscarraige

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Blocking Mifepristone Action With Progesterone
NCT03774745 TERMINATED PHASE1/PHASE2