Vaginal Progesterone for Treatment of Threatened Miscarriage (VPM)

Omar Mamdouh Shaaban

Status: Unknown

Conditions: Threatened Miscarriage

Treatments: Drug: Vaginal Progesteron

Study type: Interventional

Funder types: Other

Identifiers

NCT02690129

treatment of miscarraige

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups, including a placebo group

Group I (Progesterone Group)

Active Comparator group

Description:

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.

Treatment:

Drug: Vaginal Progesteron

Group II ( Control group)

Placebo Comparator group

Description:

Will follow the same plan of management without progesterone support.

Treatment:

Drug: Vaginal Progesteron