Pregnancy
Conditions
Keywords
preterm delivery, short cervical length, progesterone
Brief summary
Preterm deliveries play a significant role in neonatal morbidity and mortality. Previous studies showed that administration of progesterone to pregnant women at high risk, decrease spontaneous preterm deliveries. The purpose of this study is to compare between two different modes of treatment with progesterone for the prevention of preterm delivery: weekly injection of 17 alfa hydroxyprogesterone caproate versus daily vaginal administration of progesterone in terms of efficacy, comfort and compliance, safety and cost of treatments.
Interventions
DRUG17 alfa hydroxyprogesterone caproate
weekly injection of 250 mg until 34 weeks gestation
previous preterm delivery, treatment with daily vaginal progesterone 200 mg until 34 weeks gestation.
DRUGvaginal progesterone
daily vaginal progesterone 200 mg until 34 weeks gestation.
Sponsors
Meir Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* The subject has a history of spontaneous preterm delivery defined as earlier than 37 gestational week. * The subject has a short cervical length defined as 25 mm before 24 weeks gestation. * A singleton gestation.
Exclusion criteria
* Multifetal pregnancy. * The subject has or will have a cervical cerclage in place.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| comfort of use and consequently of that compliance | 3 years |
Countries
Israel
Outcome results
None listed