Nifedipine Compared to Atosiban for Treating Preterm Labor
Primary Purpose
Labor, Premature
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Atosiban
Nifedipine
Sponsored by
About this trial
This is an interventional treatment trial for Labor, Premature focused on measuring Preterm labor, Atosiban, Nifedipine
Eligibility Criteria
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
Sites / Locations
- HaEmek Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
delaying labor
Secondary Outcome Measures
drugs side effects
obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)
neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00599898
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raed Salim
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the efficacy and the safety of nifedipine compared to atosiban for treating preterm labor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor, Premature
Keywords
Preterm labor, Atosiban, Nifedipine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atosiban
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
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 Outcome Measure Information:
Title
delaying labor
Time Frame
for more than 48 hours after starting treatment
Secondary Outcome Measure Information:
Title
drugs side effects
Time Frame
within the first 48 hours after treatment
Title
obstetrical (number of days to delivery, gestational age at delivery, mode of delivery)
Time Frame
within 24 hours after delivery
Title
neonatal (Apgar score, sepsis, IVH, NEC, RDS, DEATH)
Time Frame
within 30 days from delivery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gali Garmi, MD
Organizational Affiliation
HaEmek Medical Center, Afula, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
HaEmek Medical Center
City
Afula
ZIP/Postal Code
18100
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
14712983
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.
Results Reference
background
PubMed Identifier
9241299
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.
Results Reference
background
PubMed Identifier
10819857
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.
Results Reference
background
PubMed Identifier
35947046
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.
Results Reference
derived
PubMed Identifier
23168756
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.
Results Reference
derived
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Nifedipine Compared to Atosiban for Treating Preterm Labor
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