Tocolytic Therapy for Preterm Labor in Multiple Gestation

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 3

Conditions: Labor Preterm Multiple

Treatments: Drug: Atosiban; Drug: Nifedipine

Study type: Interventional

Funder types: Other

Identifiers

NCT02725736

755-15-TLV

Details and patient eligibility

About

To compare the tocolytic efficacy oxytocin receptor antagonist (Atosiban) with that of calcium channel blockers (Nifedipine) among women with multiple gestation who present with threatened preterm labor.

Full description

Preterm birth remains the principal cause of early neonatal death. Infants born preterm (before 37 weeks' gestation) often suffer significant immediate morbidity and need lengthy stays in neonatal intensive care units. Moreover, there is a significant risk of long-term neurological morbidity in a proportion of the survivors. Patients with a multiple gestation are at significant risk for preterm labor and delivery as approximately 60% of all those pregnancies will be delivered preterm.

A number of oxytocin receptor antagonists have been developed, and of these, three, atosiban, barusiban and retosiban have been investigated in humans as tocolytic agents. To date, only atosiban is in use outside of clinical trials. Atosiban is an oxytocin receptor antagonist which was specifically developed for the treatment of preterm labor. Early reports of the use of Atosiban for tocolysis showed promise both in vitro and in animal studies, and preliminary studies in pregnant and non-pregnant humans suggested a very low incidence of maternal side effects .

Enrollment: 140 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Twin pregnancy
2. Gestational age between 24+0 and 32+6 weeks
3. Intact amniotic membranes
4. Threatened preterm labor
5. Age 18-50.

Exclusion criteria

1. Rupture of membranes
2. Vaginal bleeding resulting from placenta previa or placental abruption
3. Fever above 38°C
4. Severe preeclampsia
5. Maternal cardiovascular or liver diseases
6. Systolic blood pressure less than 90 mm Hg
7. Known uterine malformation
8. Intrauterine growth restriction below the fifth percentile
9. Non-reassuring fetal status
10. Antepartum diagnosis of major fetal malformations
11. Fetal death
12. Previous tocolytic therapy or Betamethasone treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Atosiban

Experimental group

Description:

Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Atosiban group.

Treatment:

Drug: Atosiban

Nifedipine

Experimental group

Description:

Women with twin pregnancy with preterm labor between 24 weeks 0 days and 32 weeks 6 days of gestation will be included and randomly assigned to the Nifedipine group.

Treatment:

Drug: Nifedipine