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
About this trial
This is an interventional prevention trial for Preterm Labor Without Delivery
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)
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
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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