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Status | Withdrawn |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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05048550 -
Babies in Glasses; a Feasibility Study.
|
N/A | |
Active, not recruiting |
NCT03655639 -
Local Version of the Multi-center PREVENT Study Evaluating Cardio-respiratory Instability in Premature Infants
|
||
Enrolling by invitation |
NCT05542108 -
Adding Motion to Contact: A New Model for Low-cost Family Centered Very-early Onset Intervention in Very Preterm-born Infants
|
N/A | |
Completed |
NCT03680157 -
Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
|
||
Completed |
NCT03337659 -
A Cluster Randomized Controlled Trial of FICare at 18 Months
|
N/A | |
Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
Completed |
NCT03251729 -
Cerclage On LOw Risk Singletons: Cervical Cerclage for Prevention of Spontaneous Preterm Birth in Low Risk Singleton Pregnancies With Short Cervix
|
Phase 4 | |
Not yet recruiting |
NCT05039918 -
Neonatal Experience of Social Touch
|
N/A | |
Not yet recruiting |
NCT03418311 -
Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome
|
N/A | |
Not yet recruiting |
NCT03418012 -
Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB
|
N/A | |
Not yet recruiting |
NCT02880696 -
Perception of Temporal Regularity in Tactile Stimulation: a Diffuse Correlation Spectroscopy Study in Preterm Neonates
|
N/A | |
Completed |
NCT02952950 -
Is it Possible to Prolong the Duration of Breastfeeding in Premature Infants? a Prospectivt Study
|
N/A | |
Completed |
NCT02913495 -
Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth
|
Phase 4 | |
Completed |
NCT02743572 -
Iron-fortified Parenteral Nutrition in the Prevention and Treatment of Anemia in Premature Infants
|
N/A | |
Completed |
NCT02879799 -
Family Integrated Care (FICare) in Level II NICUs
|
N/A | |
Completed |
NCT02661360 -
Effects of Swaddling on Infants During Feeding
|
N/A | |
Completed |
NCT01352234 -
Comparison of Doses of Acetylsalicylic Acid in Women With Previous History of Preeclampsia
|
Phase 4 | |
Completed |
NCT01163188 -
Social Adjustment and Quality of Life After Very Preterm Birth
|
N/A | |
Terminated |
NCT00675753 -
Three Interacting Single Nucleotide Polymorphisms (SNPs) and the Risk of Preterm Birth in Black Families
|
N/A | |
Completed |
NCT00271115 -
Kangaroo Holding and Maternal Stress
|
N/A |