Clinical trial NCT03298191: Tocolysis in Prevention of Preterm Labor
Official title: Comparative Study on Tocolysis in Prevention of Preterm Labour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Preterm Labor Without Delivery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 300
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: complications ofthe drugs good response to drugs
Primary purpose: PREVENTION

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.


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)

Primary outcomes:
measure: The time of delivery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Mohamed Atef Mohamed
Study officials:
References:
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.