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

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ClinicalTrials.gov Identifier: NCT03040752
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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

Condition or disease Intervention/treatment Phase
Preterm Birth Drug: Nifedipine 20 Mg Drug: Ritodrine Oral Tablet Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparative Study Between Nifedipine and Ritodrine as Maintenance Tocolytic Therapy in Preterm Labor: A Randomized Controlled Trial
Actual Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arm Intervention/treatment
Active Comparator: Nifedipine
nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor
Drug: Nifedipine 20 Mg
nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor
Other Name: Epilate retard

Active Comparator: Ritodrine
Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor.
Drug: Ritodrine Oral Tablet
Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor
Other Name: Yutopar




Primary Outcome Measures :
  1. gestational age at delivery [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040752


Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged Kasr Alainy medical school

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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03040752     History of Changes
Other Study ID Numbers: 157
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Nifedipine
Tocolytic Agents
Ritodrine
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Reproductive Control Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents