Tocolysis in Prevention of Preterm Labor

NCT03298191 | Unknown Phase 4

• 1 other identifier: TPL
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor Without Delivery

Outcome Measures

Primary Outcomes (1)

• The time of delivery

  6 months

Study Arms (3)

Magnesium sulphate

EXPERIMENTAL

Drug: Magnesium Sulfate

Ritodrine

EXPERIMENTAL

Drug: Ritodrine

Calcium channel blocker

EXPERIMENTAL

Drug: Calcium Channel Blockers

Interventions

Magnesium Sulfate DRUG

Those women will be given Magnesium Sulfate for tocolysis

Magnesium sulphate

Ritodrine DRUG

Those women will be given Ritodrine for tocolysis

Ritodrine

Calcium Channel Blockers DRUG

Those women will be given Calcium Channel Blockers for tocolysis

Calcium channel blocker

Eligibility Criteria

• Age: 17 Years - 40 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Mohamed Atef Mohamed

Sohag, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 35947046 DERIVED

MeSH Terms

Interventions

Magnesium Sulfate; Ritodrine; Calcium Channel Blockers

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Cardiovascular Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: false preterm labour
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: complications ofthe drugs good response to drugs

Study Record Dates

• First Submitted: August 26, 2017
• First Posted: October 2, 2017
• Study Start: October 25, 2017
• Primary Completion: April 25, 2018
• Study Completion: May 25, 2018
• Last Updated: October 2, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)