Clinical trial NCT00599898: Nifedipine Compared to Atosiban for Treating Preterm Labor
Official title: Nifedipine Compared to Atosiban for Treating Preterm Labor. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labor, Premature
Keywords: Preterm labor
Atosiban
Nifedipine
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-01-24
Enrollment: 145
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: delaying labor
timeFrame: for more than 48 hours after starting treatment
Secondary outcomes:
measure: drugs side effects
timeFrame: within the first 48 hours after treatment
measure: obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)
timeFrame: within 24 hours after delivery
measure: neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)
timeFrame: within 30 days from delivery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: HaEmek Medical Center, Afula, Israel
name: Gali Garmi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.