Threat Preterm labor
Conditions
Interventions
Trade Name: Progeffik 200 mg
Pharmaceutical Form: Vaginal capsule
INN or Proposed INN: PROGESTERONE
CAS Number: 57-83-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
Instituto de Investigacion Sanitaria La Fe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with singleton pregnancies with intact membranes have passed an episode of APP (uterine contractions with cervical change) successfully treated with acute tocolysis with atosiban. Cervical length ? 25 mm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;Inclusion criteria: Women with singleton pregnancies with intact membranes have passed an episode of APP (uterine contractions with cervical change) successfully treated with acute tocolysis with atosiban. Cervical length ? 25 mm Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cervical dilation ? 3 cm, multiple gestation, maternal medical contraindication to tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to tocolytic therapy (severe preeclampsia, intrauterine infection, placental abruption, fetal anomaly incompatible with life, fetal death). ;Exclusion criteria: Cervical dilation ? 3 cm, multiple gestation, maternal medical contraindication to tocolysis with nifedipine, atosiban or progesterone, or obstetric contraindication to tocolytic therapy (severe preeclampsia, intrauterine infection, placental abruption, fetal anomaly incompatible with life, fetal death).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the perinatal and neonatal outcome;Secondary Objective: Objectify maternal side effects of nifedipine and progesterone Evaluate the outcome of pregnancy in women treated with nifedipine or with progesterone as maintenance tocolytic after an episode of APP which has been administered acute tocolysis and corticosteroids for lung maturation in full, compared with patients treated with placebo.;Primary end point(s): Decrease preterm delivery (before 37 weeks of gestation);Timepoint(s) of evaluation of this end point: At birth.;Main Objective: To evaluate the perinatal and neonatal outcome;Secondary Objective: Objectify maternal side effects of nifedipine and progesterone Evaluate the outcome of pregnancy in women treated with nifedipine or with progesterone as maintenance tocolytic after an episode of APP which has been administered acute tocolysis and corticosteroids for lung maturation in full, compared with patients treated with placebo.;Primary end point(s): Decrease preterm delivery (before 37 weeks of gestation);Timepoint(s) of evaluation of this end point: At birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Gestational age at birth (weeks), prolongation of pregnancy in women with APP (days), the presence of a recurrent episode of APP and the presence of more than one recurrent episodes of APP). It quantifies the number of women with PP before 34 weeks gestation, before 37 weeks and after 37 weeks;Timepoint(s) of evaluation of this end point: From the beginning of treatment, during the course of pregnancy and at delivery.;Secondary end point(s): Gestational age at birth (weeks), prolongation of pregnancy in women with APP (days), the presence of a recurrent episode of APP and the presence of more than one recurrent episodes of APP). It quantifies the number of women with PP before 34 weeks gestation, before 37 weeks and after 37 weeks;Timepoint(s) of evaluation of this end point: From the beginning of treatment, during the course of pregnancy and at delivery. | — |
Countries
Spain
Contacts
Public ContactUREC;UREC ;
Instituto de Investigacion Sanitaria La Fe;Instituto de Investigacion Sanitaria La Fe
Outcome results
None listed