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Tocolysis in Prevention of Preterm Labor

NCT ID: NCT03298191

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-25

Study Completion Date

2018-05-25

Brief Summary

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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.

Detailed Description

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Conditions

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Preterm Labor Without Delivery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

complications ofthe drugs good response to drugs
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
false preterm labour

Study Groups

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Magnesium sulphate

Group Type EXPERIMENTAL

Magnesium Sulfate

Intervention Type DRUG

Those women will be given Magnesium Sulfate for tocolysis

Ritodrine

Group Type EXPERIMENTAL

Ritodrine

Intervention Type DRUG

Those women will be given Ritodrine for tocolysis

Calcium channel blocker

Group Type EXPERIMENTAL

Calcium Channel Blockers

Intervention Type DRUG

Those women will be given Calcium Channel Blockers for tocolysis

Interventions

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Magnesium Sulfate

Those women will be given Magnesium Sulfate for tocolysis

Intervention Type DRUG

Ritodrine

Those women will be given Ritodrine for tocolysis

Intervention Type DRUG

Calcium Channel Blockers

Those women will be given Calcium Channel Blockers for tocolysis

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

17 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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mohamed atef mohamed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohamed Atef Mohamed

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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mohamed mohamed

Role: primary

[email protected]
+01005537951

References

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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.

Reference Type DERIVED
PMID: 35947046 (View on PubMed)

Other Identifiers

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TPL

Identifier Type: -

Identifier Source: org_study_id