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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03298191
Other study ID # TPL
Secondary ID
Status Recruiting
Phase Phase 4
First received August 26, 2017
Last updated September 26, 2017
Start date October 25, 2017
Est. completion date May 25, 2018

Study information

Verified date September 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date May 25, 2018
Est. primary completion date April 25, 2018
Accepts healthy volunteers No
Gender Female
Age group 17 Years to 40 Years
Eligibility 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)

Study Design


Intervention

Drug:
Magnesium Sulfate
Those women will be given Magnesium Sulfate for tocolysis
Ritodrine
Those women will be given Ritodrine for tocolysis
Calcium Channel Blockers
Those women will be given Calcium Channel Blockers for tocolysis

Locations

Country Name City State
Egypt Mohamed Atef Mohamed Sohag

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary The time of delivery 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT05520021 - The Treatment of Magnesium Sulfate and Nifedipine in Preterm Labor Threat N/A
Not yet recruiting NCT04644354 - The Efficacy of Nifedipine in the Management of Preterm Labor