THREATENED PRETERM DELIVERY MedDRA version: 9.1 Level: SOC Classification code 10036585
Conditions
Interventions
Trade Name: LENTOGEST*IM 1F 341MG/2ML
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: Hydroxyprogesterone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
U.O. Ginecologia e Ostetricia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Women with singleton pregnancy at 22nd to 32nd week of gestation presenting with a cervical length ≤25 mm, even after an episode of preterm labour. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Women with previous spontaneous PTD, multiple pregnancy, rupture of membranes, feto-maternal conditions indicating delivery, cervix dilated >2 cm or shorter than 5 mm, presence of regular uterine contractions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This trial would compare the effect of P and 17P in reducing PTD, in women at risk because of cervical shortening.;Secondary Objective: Gestational age at delivery, Delivery <32, <35 wks, hospital admissions before delivery, birth-weight, NICU admission, days of NICU admission, days of oxygen supply, composite neonatal complications.;Primary end point(s): Delivery before 37 weeks. | — |
Countries
Italy
Outcome results
None listed