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

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Pregnancy

Treatments: Drug: vaginal progesterone; Drug: natural progesterone; Drug: 17 alfa hydroxyprogesterone caproate

Study type: Interventional

Funder types: Other

Identifiers

NCT00809939

0129-08-MMC Ver:1

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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800 participants in 4 patient groups

1

Active Comparator group

Description:

previous preterm delivery, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.

Treatment:

Drug: 17 alfa hydroxyprogesterone caproate

Drug: 17 alfa hydroxyprogesterone caproate

2

Active Comparator group

Description:

previous preterm delivery, treatment with daily vaginal natural progesterone

Treatment:

Drug: natural progesterone

3

Active Comparator group

Description:

short cervical length, treatment with weekly injections of 17 alfa hydroxyprogesterone caproate.

Treatment:

Drug: 17 alfa hydroxyprogesterone caproate

Drug: 17 alfa hydroxyprogesterone caproate

4

Active Comparator group

Description:

short cervical length, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.

Treatment:

Drug: vaginal progesterone