Nifedipine Compared to Atosiban for Treating Preterm Labor

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raed Salim, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00599898
First received: January 8, 2008
Last updated: March 12, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.


Condition Intervention Phase
Labor, Premature
Drug: Atosiban
Drug: Nifedipine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • delaying labor [ Time Frame: for more than 48 hours after starting treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • drugs side effects [ Time Frame: within the first 48 hours after treatment ] [ Designated as safety issue: Yes ]
  • obstetrical (number of days to delivery, gestational age at delivery, mode of delivery) [ Time Frame: within 24 hours after delivery ] [ Designated as safety issue: No ]
  • neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH) [ Time Frame: within 30 days from delivery ] [ Designated as safety issue: Yes ]

Enrollment: 145
Study Start Date: January 2008
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Atosiban
Atosiban group will receive an atosiban bolus (6.75 mg) over 1 min then an intravenous infusion of 300mcg/min for 3 h followed by 100mcg/min for another 45h. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, atosiban will be stopped and the women will receive nifedipine as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.
Experimental: 2 Drug: Nifedipine
Nifedipine group: the initial dose will be 20 mg (one tab) orally every 20 min for 3 doses. If the contractions is inhibited, a maintenance dose of 20 - 40 mg every 6 h up to 48 h will be followed. If contractions continue or recur within 48 hours or the dilatation of the cervix progresses by 1 cm or more within 48 hours, nifedipine will be stopped and the women will receive atosiban as a 2nd line (see arm 2). If the second line fails and gestational age is less than 28 weeks, indomethacin will be administered as a 3rd line.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
  2. All women fulfilled the criteria of preterm labor. The diagnosis of preterm labor required the presence of 4 uterine contractions or more over 30 minutes, each lasting at least 30 seconds, and documented cervical change. The cervical criteria were met when either of the following was present:

    1. Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
    2. Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
  3. Provision of written informed consent

Exclusion Criteria:

  1. Chorioamnionitis
  2. Preterm rupture of membranes
  3. Vaginal bleeding
  4. Major fetal malformations
  5. Severe hypertensive disorders
  6. Intrauterine growth restriction (< 5th percentile).
  7. Non-reassuring fetal heart rate
  8. Maternal contraindications

    1. Chronic hypertension
    2. Systolic blood pressure < 90 mmHg
    3. Cardiovascular disease
    4. Elevated hepatic enzymes
  9. Congenital or acquired uterine malformation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599898

Locations
Israel
HaEmek Medical Center
Afula, Israel, 18100
Sponsors and Collaborators
Raed Salim
Investigators
Principal Investigator: Gali Garmi, MD HaEmek Medical Center, Afula, Israel
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raed Salim, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00599898     History of Changes
Other Study ID Numbers: EMC070048CTIL, same as unique protocol ID
Study First Received: January 8, 2008
Last Updated: March 12, 2012
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by HaEmek Medical Center, Israel:
Preterm labor
Atosiban
Nifedipine

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Atosiban
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Vasodilator Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014