Vaginal Progesterone for Treatment of Threatened Miscarriage

NCT02690129 | Unknown DMC

• 1 other identifier: treatment of miscarraige
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Threatened Miscarriage

Keywords

progesterone; threatened abortion

Outcome Measures

Primary Outcomes (1)

• Miscarriage rate up to 28 weeks of gestation

  Completed 28th week

Secondary Outcomes (1)

• Gestational age at delivery or termination of pregnancy

  Number of completed weeks at the time of delivery

Study Arms (2)

Group I (Progesterone Group)

ACTIVE COMPARATOR

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.

Drug: Vaginal Progesteron

Group II ( Control group)

PLACEBO COMPARATOR

Will follow the same plan of management without progesterone support.

Drug: Vaginal Progesteron

Interventions

Vaginal Progesteron DRUG

Also known as: Progesterone

Group I (Progesterone Group); Group II ( Control group)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Omar Mamdouh Shaaban: lead

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Abortion, Threatened

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

Omar M Shaaban, MD

CONTACT

+201223971457; omshaaban2000@yahoo.com

Hany Abdel-aleem, MD

CONTACT

+2088414927; aleemh@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: February 24, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2018
• Last Updated: February 24, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)