Prevention of premature birth by Nifedipine alone or with Indomethaci

Phase 3

• Conditions: Pregnancy and Childbirth

• Registration Number: PACTR202004681537890
• Lead Sponsor: Mohammed Haider Hassan Ibrahim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Female
• Target Recruitment: 346

Inclusion Criteria

Women,
aged =18 years,
who diagnosed as threatened preterm labor patient
And their gestational age is between 25 and 34 weeks are eligible for this trial participation.
The diagnosis of threatened preterm labor is defined by uterine contractions, at least 3 contractions per 30 minutes, and one of the following: 1- a cervical length of =10 mm or 2) a cervical length of 11-30 mm 3- ruptured amniotic membranes.
Patients with singleton or twin pregnancies are eligible,
Any fetus position will be included.

Exclusion Criteria

Any condition considered as contra-indication for tocolysis (i.e hypertension or use of anti-hypertensive medication, signs of fetal distress or intrauterine infection, severe vaginal bleeding, myocardial infarction (less than1 month), unstable angina pectoris),
more than 5 cm cervical dilatation,
cerclage,
suspicion in neonatal chromosomal or structural anomalies and tocolytic treatment for more than 6 hours prior to arrival in a participating hospital.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be an estimation of the tocolytic efficacy and safety profile of the tocolytic therapies Indomethacin/Nifedipine combination versus Nifedipine monotherapy on delivering mother, which will be assessed in terms of the proportion of women who will not deliver and who will not need an alternate tocolytic medication within 48 hours after the first administration of the study drug. Safety assessment will be by assessing maternal associated adverse effects that included maternal tachycardia (i.e. heart rate above 120 beats per minute), hypotension (i.e. systolic blood pressure less than 90 mm Hg), other symptoms like palpitations, headache, nausea, vomiting, itching, and rash.

Secondary Outcome Measures

Name	Time	Method
To estimate associated neonatal morbidity and mortality may associate with the tocolytic therapies Indomethacin/Nifedipine combination versus Nifedipine monotherapy which includes gestational age at delivery and neonatal morbidity and mortality related to prematurity (lung diseases, severe intraventricular hemorrhage, periventricular leukomalacia, sepsis, necrotizing enterocolitis), gestational age at delivery. That will be assessed until discharge from the hospital or neonatal death.