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NCT00599898·Phase 4·INTERVENTIONAL

Nifedipine Compared to Atosiban for Treating Preterm Labor

AtosibanOtherCompleted

Status

Completed

Phase

Phase 4

Enrollment

145

Locations

1

Results

Not posted

Publications

5

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jan 24, 2008

  2. Study start

    Jan 2008

  3. Primary completion

    Dec 2011

  4. Study completion

    Feb 2012

  5. Results posted

    Not reported

  6. Registry updated

    Mar 13, 2012

Outcomes

What the study measures.

Primary outcomes

delaying labor

Time frame · for more than 48 hours after starting treatment

Secondary outcomes

drugs side effects

Time frame · within the first 48 hours after treatment

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

Time frame · within 24 hours after delivery

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

Time frame · within 30 days from delivery

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
No

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

Study locations

1 registered sites.

Israel. Showing up to 24 locations stored in the fast local snapshot.

HaEmek Medical Center

Afula, Israel

Publications

Results and literature.

PMID 14712983 ↗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 9241299 ↗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 10819857 ↗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 35947046 ↗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 23168756 ↗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.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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Put the record in context.

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