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

NCT00809939 | Unknown Phase 3

• 1 other identifier: 0129-08-MMC Ver:1
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy

Keywords

preterm delivery; short cervical length; progesterone

Outcome Measures

Primary Outcomes (1)

• efficacy

  3 years

Secondary Outcomes (1)

• comfort of use and consequently of that compliance

  3 years

Study Arms (4)

1

ACTIVE COMPARATOR

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

Drug: 17 alfa hydroxyprogesterone caproate

2

ACTIVE COMPARATOR

previous preterm delivery, treatment with daily vaginal natural progesterone

Drug: natural progesterone

3

ACTIVE COMPARATOR

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

Drug: 17 alfa hydroxyprogesterone caproate

4

ACTIVE COMPARATOR

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

Drug: vaginal progesterone

Interventions

17 alfa hydroxyprogesterone caproate DRUG

weekly injection of 250 mg until 34 weeks gestation

1

natural progesterone DRUG

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

2

vaginal progesterone DRUG

daily vaginal progesterone 200 mg until 34 weeks gestation.

4

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Multifetal pregnancy.
• The subject has or will have a cervical cerclage in place.

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tal Biron-Shental, MD

  Meir Medical Center, Israel, Affiliated to Tel Aviv University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 30, 2011

Record last verified: 2011-08

Locations

IL (1)