Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 8, 2008
March 12, 2012
January 2008
December 2011   (final data collection date for primary outcome measure)
delaying labor [ Time Frame: for more than 48 hours after starting treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00599898 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Nifedipine Compared to Atosiban for Treating Preterm Labor
Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Labor, Premature
  • 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.
  • 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.
  • Experimental: 1
    Intervention: Drug: Atosiban
  • Experimental: 2
    Intervention: Drug: Nifedipine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
February 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00599898
EMC070048CTIL, same as unique protocol ID
No
Raed Salim, HaEmek Medical Center, Israel
Raed Salim
Not Provided
Principal Investigator: Gali Garmi, MD HaEmek Medical Center, Afula, Israel
HaEmek Medical Center, Israel
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP