17 Alfa Hydroxyprogesterone Caproate Versus Natural Progesterone for the Prevention of Preterm Labor

Meir Medical Center800 enrolled

Overview

Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries. The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

800

Conditions

Pregnancy

Interventions

17 alfa hydroxyprogesterone caproateDRUG

weekly injection of 250 mg until 34 weeks gestation

natural progesteroneDRUG

previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.

17 alfa hydroxyprogesterone caproateDRUG

weekly injection, 250 mg until 34 weeks gestation

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week. * The subject has a short cervical length defined as 25 mm before 24 weeks gestation. * A singleton gestation. Exclusion Criteria: * Multifetal pregnancy. * The subject has or will have a cervical cerclage in place.

Locations (1)

Meir Medical Center

Kfar Saba, Israel

Outcomes

Primary Outcomes

efficacy

Time frame: 3 years

Secondary Outcomes

comfort of use and consequently of that compliance

Time frame: 3 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.