Progesterone Supplementation in Threatened Abortion (Prothreat)

Tanta University

Status and phase: Completed; Phase 4

Conditions: Threatened Abortion; Progesterone Resistance

Treatments: Drug: Placebos; Drug: Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT03930212

Prog133077

Details and patient eligibility

About

To decide whether progesterone supplementation in threatened abortion is a sound practice.

Full description

This study was conducted at Obstetrics and Gynecology Department, Tanta University in the period from January 2018 to December 2018. Patients: Eligible patients (n=190) were randomly allocated into 2 groups; study group who will receive progesterone supplementation (Prog.group) and control group who will receive no treatment (place.group).

Enrollment: 190 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• threatened abortion diagnosed by history and ultrasound examination
• singleton
• viable fetus
• gestational age < 20 weeks
• closed normal length cervix.

Exclusion criteria

• short cervix <2 cm Multiple pregnancy
• dead fetus
• open cervix ≥ 2cm
• history of cervical surgery
• refusal to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups, including a placebo group

Progesterone

Experimental group

Description:

received rectal progesterone suppositories 400 mg once daily

Treatment:

Drug: Progesterone

Control group

Placebo Comparator group

Description:

received placebo suppositories rectally once daily.

Treatment:

Drug: Placebos