Nifedipine Compared to Atosiban for Treating Preterm Labor

NCT00599898 | Completed Phase 4

• 2 other identifiers: EMC070048CTILsame as unique protocol ID
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Labor, Premature

Keywords

Preterm labor; Atosiban; Nifedipine

Outcome Measures

Primary Outcomes (1)

• delaying labor

  for more than 48 hours after starting treatment

Secondary Outcomes (3)

• drugs side effects

  within the first 48 hours after treatment

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

  within 24 hours after delivery

• neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)

  within 30 days from delivery

Study Arms (2)

1

EXPERIMENTAL

Drug: Atosiban

2

EXPERIMENTAL

Drug: Nifedipine

Interventions

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.

1

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.

2

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raed Salim: lead

Study Sites (1)

HaEmek Medical Center

Afula, 18100, Israel

Location

Related Publications (5)

• King JF, Flenady V, Papatsonis D, Dekker G, Carbonne B. Calcium channel blockers for inhibiting preterm labour; a systematic review of the evidence and a protocol for administration of nifedipine. Aust N Z J Obstet Gynaecol. 2003 Jun;43(3):192-8. doi: 10.1046/j.0004-8666.2003.00074.x.

  PMID: 14712983 BACKGROUND

• Papatsonis DN, Van Geijn HP, Ader HJ, Lange FM, Bleker OP, Dekker GA. Nifedipine and ritodrine in the management of preterm labor: a randomized multicenter trial. Obstet Gynecol. 1997 Aug;90(2):230-4. doi: 10.1016/S0029-7844(97)00182-8.

  PMID: 9241299 BACKGROUND

• Moutquin JM, Sherman D, Cohen H, Mohide PT, Hochner-Celnikier D, Fejgin M, Liston RM, Dansereau J, Mazor M, Shalev E, Boucher M, Glezerman M, Zimmer EZ, Rabinovici J. Double-blind, randomized, controlled trial of atosiban and ritodrine in the treatment of preterm labor: a multicenter effectiveness and safety study. Am J Obstet Gynecol. 2000 May;182(5):1191-9. doi: 10.1067/mob.2000.104950.

  PMID: 10819857 BACKGROUND

• Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.

  PMID: 35947046 DERIVED

• Salim R, Garmi G, Nachum Z, Zafran N, Baram S, Shalev E. Nifedipine compared with atosiban for treating preterm labor: a randomized controlled trial. Obstet Gynecol. 2012 Dec;120(6):1323-31. doi: 10.1097/aog.0b013e3182755dff.

  PMID: 23168756 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

atosiban; Nifedipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Gali Garmi, MD

  HaEmek Medical Center, Afula, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 24, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: February 1, 2012
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

IL (1)