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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

About this trial

This is an interventional treatment trial for Labor, Premature focused on measuring Preterm labor, Atosiban, Nifedipine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:
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%.
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
1. Chronic hypertension
2. Systolic blood pressure < 90 mmHg
3. Cardiovascular disease
4. Elevated hepatic enzymes
Congenital or acquired uterine malformation

Sites / Locations

HaEmek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

NCT ID

NCT00599898

First Posted

January 8, 2008

Last Updated

March 12, 2012

Sponsor

Raed Salim

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

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

Arm Type

Experimental

Arm Title

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

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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