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Tocolysis in Prevention of Preterm Labor

Primary Purpose

Preterm Labor Without Delivery

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Magnesium Sulfate
Ritodrine
Calcium Channel Blockers
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Labor Without Delivery

Eligibility Criteria

17 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Mohamed Atef MohamedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Magnesium sulphate

Ritodrine

Calcium channel blocker

Arm Description

Outcomes

Primary Outcome Measures

The time of delivery

Secondary Outcome Measures

Full Information

First Posted
August 26, 2017
Last Updated
September 26, 2017
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03298191
Brief Title
Tocolysis in Prevention of Preterm Labor
Official Title
Comparative Study on Tocolysis in Prevention of Preterm Labour
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2017 (Anticipated)
Primary Completion Date
April 25, 2018 (Anticipated)
Study Completion Date
May 25, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor Without Delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
complications ofthe drugs good response to drugs
Masking
Participant
Masking Description
false preterm labour
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulphate
Arm Type
Experimental
Arm Title
Ritodrine
Arm Type
Experimental
Arm Title
Calcium channel blocker
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Those women will be given Magnesium Sulfate for tocolysis
Intervention Type
Drug
Intervention Name(s)
Ritodrine
Intervention Description
Those women will be given Ritodrine for tocolysis
Intervention Type
Drug
Intervention Name(s)
Calcium Channel Blockers
Intervention Description
Those women will be given Calcium Channel Blockers for tocolysis
Primary Outcome Measure Information:
Title
The time of delivery
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Mohamed Atef Mohamed
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed mohamed
Phone
+01005537951
Email
mohammedelksoy@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35947046
Citation
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.
Results Reference
derived

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Tocolysis in Prevention of Preterm Labor

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