Preterm Labor Without Delivery Clinical Trial
Official title:
Comparative Study on Tocolysis in Prevention of Preterm Labour
| Verified date | September 2017 |
| Source | Assiut University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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) |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Mohamed Atef Mohamed | Sohag |
| Lead Sponsor | Collaborator |
|---|---|
| Assiut University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The time of delivery | 6 months |
| 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
|