Tocolysis in Prevention of Preterm Labor

Phase 4

• Conditions: Preterm Labor Without Delivery
• Interventions: Drug: Calcium Channel Blockers; Drug: Ritodrine; Drug: Magnesium Sulfate

• Registration Number: NCT03298191
• Lead Sponsor: Assiut University

Brief Summary

Preterm birth is defined as birth before 37 completed weeks of gestation .it occurs in 11.1%of birth globally affecting an estimated 14.9 million babies every year . It is generally accepted that approximately 65%-70%of preterm births are spontaneous,40%-45% of them due to spontaneous preterm labor and 25%-30%following preterm rupture of membranes.preterm birth represents the single largest cause of morbidity and mortality for newborn and is estimated for 29%of deaths in the first four weeks of life and also is estimated for of major cause of morbidity for pregnant women .

Tocolytic agents include a wide range of drugs that can slow or suppress uterine contractions . Tocolytic are considered advantages in spontaneous preterm labor to : (a) allow time for the fetus to mature ,potentially avoiding deleterious effects of pre-maturity . (b)allow time for antenatal corticosteroids to be administered and have clinical effect. (c) allow time for intrauterine transfer to higher-care center where neonatal intensive care facilities are available . the ideal Tocolytic agent should be effective , easy to administer , without significant material ,fetal or neonatal side effects and permit time for antenatal corticosteroids to be administered and take effect . a variety of Tocolytic treatments have been used to inhibit uterine activity in women in spontaneous preterm labor , including betamimetics , calcium channel blockers , magnesium sulfate , prostaglandin inhibitors and oxytocin receptor antagonists however there is considerable global variation in types , doses and regimens of tocolytic agents uses to manage preterm labor .

A comparison study between Ritodrine, magnesium sulfate and Nifedipine in terms of effect and morbidity will be conducted.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-26
• Status Verified: 2017-09
• Study First Submitted QC: 2017-09-26
• Last Update Submitted: 2017-09-26
• Study First Posted: 2017-10-02
• Last Update Posted: 2017-10-02
• Study Start: 2017-10-25
• Primary Completion: 2018-04-25
• Study Completion: 2018-05-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• . Gestational age between 24-37weeks

  • Symptoms such as low backache , cramping ,pelvic pressure, excessive vaginal discharge and vaginal spotting .
  • Regular uterine contractions at least of 30 seconds duration at a rate of more than 4/30 minutes
  • Cervical changes dilatation less than 3cm,effacement lessthan50%.
  • Intact membranes.

Exclusion criteria

• Active vaginal bleeding and placental abruption.
• Chorioamnionitis and intrauterine infection
• Fetal conditions : fetal death or distress, lethal congenital or chromosomal abnormalities and intra uterine growth restriction
• Maternal conditions indicate that pregnancy shouldn't be continued: eclampsia , severe preeclampsia and cardiac diseases
• Drug specific contraindications(contraindication of tocolysis)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calcium channel blocker	Calcium Channel Blockers	-
Ritodrine	Ritodrine	-
Magnesium sulphate	Magnesium Sulfate	-

Primary Outcome Measures

Name	Time	Method
The time of delivery	6 months

Trial Locations

Locations (1)

Mohamed Atef Mohamed; 🇪🇬 Sohag, Egypt