Short-Term Tocolysis in Preterm Labor

Sohag University

Status: Begins enrollment this month

Conditions: Preterm Labor

Study type: Observational

Funder types: Other

Identifiers

NCT07696858

Soh-Med-26-6-26MS

Details and patient eligibility

About

The aim of this study is to identify independent prognostic factors associated with the success of short-term tocolysis, defined as delivery delayed by at least 48 hours, in women with singleton preterm labor

Full description

All participants will receive short-term tocolytic therapy according to the unit protocol.

• The choice of tocolytic agent (., Magnesium sulphate ) will be determined by the treating physician.
• Tocolysis will be administered for a maximum duration of 48-72 hours.
• Antenatal corticosteroids (Betamethasone amp 12mg once daily for 2days) will be administered to eligible participants to enhance fetal lung maturity.
• Failure documented when there is efficient uterine contractions more 4/10mins each one lasts more than 40 seconds, and there was progressive cervical dilatation more 3cm

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 18 to 45 years old.
• Singleton Pregnancy
• Gestational age between 24 and 34 weeks, confirmed by last menstrual period and/or first-trimester ultrasound.
• Diagnosis of preterm labor, defined as Regular uterine contractions (≥4 in 20 minutes recorded in CTG) with a documented change in cervical dilation (e.g., from<1 cm to ≥2 cm) or, in nulliparous women, a dilation of ≥2 cm
• Intact membranes at the time of presentation.

Exclusion criteria

Established preterm labor (efficient uterine contractions 4/10mins each one lasts more than 40 Seconds recorded in CTG, with cervical changes (dilatation>4cm, effacement>80%)).

• Evidence of chorioamnionitis or intrauterine infection.
• Preterm premature rupture of membranes (PPROM).
• Maternal medical disorders contraindicating tocolysis, such as severe preeclampsia, significant cardiac disease, or uncontrolled diabetes mellitus.
• Contraindications to continuation of pregnancy, including placental abruption or placenta previa with bleeding.
• Vaginal bleeding of unknown origin" as a specific exclusion criterion, as it may indicate abruption or other pathologies.