Premature Birth Clinical Trial
Official title:
The Impact of Progesterone Treatment on Obstetrical Outcome Among Women With First Trimester Vaginal Bleeding
Verified date | October 2016 |
Source | Soroka University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
The purpose of this study is to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Low risk pregnancies - Intrauterine pregnancy documented sonographically - Singleton pregnancy - Known gestational age - Healthy women Exclusion Criteria: - Women after reproductive assistant techniques - Women treated with progesterone - Multiple pregnancies |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Israel | Soroka University Medical Center | Beer Sheva |
Lead Sponsor | Collaborator |
---|---|
Soroka University Medical Center |
Israel,
Lykke JA, Dideriksen KL, Lidegaard O, Langhoff-Roos J. First-trimester vaginal bleeding and complications later in pregnancy. Obstet Gynecol. 2010 May;115(5):935-44. doi: 10.1097/AOG.0b013e3181da8d38. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | adverse pregnancy outcomes | Miscarriage (also gestational age of miscarriage) Sonographic Intrauterine hematoma IUGR Placenta previa Pregnancy induced hypertension and preeclampsia/eclampsia Gestational age at delivery - Preterm delivery (before 37w); Early Preterm delivery (before 34w); and very early (before 28w) Mode of delivery Placental abruption PPROM Induction of labor PPH Apgar score Umbilical cord blood PH at birth Birth weight Fetal malformations Perinatal mortality Admission to the neonatal unit | 9 months | No |
Secondary | Uterine artery blood flow velocimetry | Systolic to diastolic ratio, pulsatility index, resistance index and peak systolic velocity | One month after recruitment upon completion of treatment | No |
Secondary | Placental pathological examination | Placental weight and presence of infarcts, calcifications, fibrin deposits or signs of inflammation | After delivey participants will be followed for the duration of hospital stay, an expected average of 3 days | No |
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