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Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor

Primary Purpose

Preterm Birth

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Nifedipine 20 Mg
Ritodrine Oral Tablet
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women included in the study were diagnosed as preterm labor defined according to American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (2012) with regular contractions before 37 weeks that are associated with cervical change .

Regular uterine contractions means at least 4 in 20 minutes or 8 in 60 minutes) and cervical changes are either cervical dilation more than 1 cm, and/or cervical effacement ≥ 80%. Threatened preterm labour was defined as contractions without any appreciable cervical changes. Women included were between 18 and 40 years old at gestational age between 28 and 34 weeks

Exclusion Criteria:

  • Women with failed tocolytic treatment to stop uterine contractions,
  • those with established preterm labor (cervical dilatation ≥ 4 cm),
  • multifetal pregnancy
  • fetal anomalies
  • those with contraindication of continuation of pregnancy (antepartum hemorrhage, premature rupture of membranes, evidence of intrauterine infections or non reassuring fetal heart rate tracing)

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nifedipine

Ritodrine

Arm Description

nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor

Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor.

Outcomes

Primary Outcome Measures

gestational age at delivery

Secondary Outcome Measures

Full Information

First Posted
January 31, 2017
Last Updated
September 20, 2019
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03040752
Brief Title
Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor
Official Title
Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A randomized controlled double blinded study included 200 women with preterm contractions. After successful arrest of contractions women were randomized into 2 equal groups: GI women received nifedipine 20 mg tablets twice daily and GII women received Ritodrine 5 mg tablets every 6 hours. The primary outcome was gestational age at delivery and the secondary outcomes include episodes of recurrent preterm labor, mode of delivery, maternal side effects and neonatal outcome
Detailed Description
Women included in the study were diagnosed as preterm labor defined according to American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (2012) with regular contractions before 37 weeks that are associated with cervical change [12]. Regular uterine contractions means at least 4 in 20 minutes or 8 in 60 minutes) and cervical changes are either cervical dilation more than 1 cm, and/or cervical effacement ≥ 80%. Threatened preterm labour was defined as contractions without any appreciable cervical changes. Women included were between 18 and 40 years old at gestational age between 28 and 34 weeks. Women with failed tocolytic treatment to stop uterine contractions, those with established preterm labor (cervical dilatation ≥ 4 cm), with multifetal pregnancy, fetal anomalies or those with contraindication of continuation of pregnancy (antepartum hemorrhage, premature rupture of membranes, evidence of intrauterine infections or non reassuring fetal heart rate tracing) were excluded from the study. During the pre-selection visit, exclusion and inclusion criteria were applied; with recording of full medical history, findings on abdominal ,local and ultrasound examination. When the patient's consent was obtained, digital vaginal examination was done prior to start of medication Treatment of TPL was achieved through Indomethacin administered rectally. A dose of 50 to 100 mg is followed at 8-hour intervals not to exceed a total 24-hour dose of 200 mg for a maximum of 48 hours [4]. After successful arrest of contractions women were randomized using automated web based randomization system ensuring allocation concealment into 2 equal groups: GI women received nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor(The cost is 20 tab=5.20 LE) and GII women received Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor.(The cost is 20 tab=20LE Treatment was maintained till 37 weeks of gestation unless established preterm delivery commence

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine
Arm Type
Active Comparator
Arm Description
nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor
Arm Title
Ritodrine
Arm Type
Active Comparator
Arm Description
Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor.
Intervention Type
Drug
Intervention Name(s)
Nifedipine 20 Mg
Other Intervention Name(s)
Epilate retard
Intervention Description
nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor
Intervention Type
Drug
Intervention Name(s)
Ritodrine Oral Tablet
Other Intervention Name(s)
Yutopar
Intervention Description
Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor
Primary Outcome Measure Information:
Title
gestational age at delivery
Time Frame
8 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women included in the study were diagnosed as preterm labor defined according to American Academy of Pediatrics and the American College of Obstetricians and Gynecologists (2012) with regular contractions before 37 weeks that are associated with cervical change . Regular uterine contractions means at least 4 in 20 minutes or 8 in 60 minutes) and cervical changes are either cervical dilation more than 1 cm, and/or cervical effacement ≥ 80%. Threatened preterm labour was defined as contractions without any appreciable cervical changes. Women included were between 18 and 40 years old at gestational age between 28 and 34 weeks Exclusion Criteria: Women with failed tocolytic treatment to stop uterine contractions, those with established preterm labor (cervical dilatation ≥ 4 cm), multifetal pregnancy fetal anomalies those with contraindication of continuation of pregnancy (antepartum hemorrhage, premature rupture of membranes, evidence of intrauterine infections or non reassuring fetal heart rate tracing)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged
Organizational Affiliation
Kasr Alainy medical school
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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

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Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor

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