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

NCT ID: NCT03040752

Last Updated: 2019-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-01-31

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

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Nifedipine

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

Group Type: ACTIVE_COMPARATOR

Nifedipine 20 Mg

Intervention Type: DRUG

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

Ritodrine

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

Group Type: ACTIVE_COMPARATOR

Ritodrine Oral Tablet

Intervention Type: DRUG

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

Interventions

Nifedipine 20 Mg

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

Intervention Type: DRUG

Ritodrine Oral Tablet

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

Intervention Type: DRUG

Other Intervention Names

Epilate retard; Yutopar

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 35947046 (View on PubMed)

Other Identifiers

157

Identifier Type: -

Identifier Source: org_study_id