Skip to main content
OpenTrials
Completed

NCT Number: NCT00599898

Nifedipine Compared to Atosiban for Treating Preterm Labor

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

HaEmek Medical Center

Afula, 18100, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age between 24 to 34 weeks which had been documented by a definite LMP and sonography up to 20 weeks.
  • 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:
  • Nulliparous women: a single cervical examination demonstrating dilatation of 0 cm to 4 cm and effacement of at least 50%
  • Multiparous women: a single cervical examination demonstrating dilatation of 1 cm to 4 cm and effacement of at least 50%.
  • Provision of written informed consent

Exclusion criteria

  • Chorioamnionitis
  • Preterm rupture of membranes
  • Vaginal bleeding
  • Major fetal malformations
  • Severe hypertensive disorders
  • Intrauterine growth restriction (< 5th percentile).
  • Non-reassuring fetal heart rate
  • Maternal contraindications
  • Chronic hypertension
  • Systolic blood pressure < 90 mmHg
  • Cardiovascular disease
  • Elevated hepatic enzymes
  • Congenital or acquired uterine malformation

Treatment and study plan

Atosiban

Drug

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.

nifedipine

Drug

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.

Primary outcomes

  1. delaying labor

    Time frame: for more than 48 hours after starting treatment

Secondary outcomes

  1. drugs side effects

    Time frame: within the first 48 hours after treatment

  2. obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)

    Time frame: within 24 hours after delivery

  3. neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)

    Time frame: within 30 days from delivery

Sponsors and collaborators

Lead sponsor

Raed Salim

Other

Registry information

Official study title

Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 24, 2008
Registry last updated
Mar 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.