CClinicalTrials.gg
Status unknownNCT03298191Updated Oct 2, 2017

Tocolysis in Prevention of Preterm Labor

A Phase 4 interventional study of Magnesium Sulfate and Ritodrine in Preterm Labor Without Delivery, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to female participants aged 17 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-10-02.

Sponsored by Assiut University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
17 Years to 40 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Preterm Labor Without Delivery
03

Who can participate

Ages eligible
17 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Magnesium sulphate

    Drug: Magnesium Sulfate

  • Experimental
    Ritodrine

    Drug: Ritodrine

  • Experimental
    Calcium channel blocker

    Drug: Calcium Channel Blockers

Interventions

  • DrugMagnesium Sulfate

    Those women will be given Magnesium Sulfate for tocolysis

  • DrugRitodrine

    Those women will be given Ritodrine for tocolysis

  • DrugCalcium Channel Blockers

    Those women will be given Calcium Channel Blockers for tocolysis

05

What researchers measure

Primary outcomes

  1. The time of delivery

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
07

References and documents

Publications

  • 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. PubMed 35947046 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03298191
Lead sponsor
Assiut University
Responsible party
mohamed atef mohamed (principal investigator, Assiut University) — Principal investigator
First posted
Oct 2, 2017
Start date
Oct 25, 2017 (estimated)
Primary completion
Apr 25, 2018 (estimated)
Completion
May 25, 2018 (estimated)
Last update
Oct 2, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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