Progesterone for First Trimester Vaginal Bleeding

Study Overview
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Brief Summary
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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.

Detailed Description
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First trimester vaginal bleeding is one of the most common pregnancy complications affecting 15-25% of all pregnancies. Threatened abortion is defined as bleeding through a closed cervical os in the first half of pregnancy. A subchorionic hematoma (SCH) is found in 18-39% of women with a threatened miscarriage and around 70% of women with a SCH will experience vaginal bleeding. Data on the relationship between first trimester vaginal bleeding and obstetric outcome is described mainly in retrospective and noncontrolled studies. It is hypothesized that first trimester bleeding is an indicator of a general tendency for complications (such as: preterm premature rupture of membranes (PPROM), preterm delivery (< 37 weeks gestation; PTD) low birth weight (<1500g; LBW) neonates, small for gestational age (SGA) neonates, placenta previa, placental abruption and stillbirth) later on in pregnancy. Nowadays, there are not scientific based treatments for the prevention of complications associated with SCH and vaginal bleeding. Nevertheless, recent data have suggested that prophylactic administration of progesterone leads to a significant reduction in the rate of preterm deliveries and SGA neonates among patients with PTD or SGA neonates in the past. Although progesterone administration for threatened miscarriage was not studied, many physicians treat patients with first trimester vaginal bleeding with progesterone. In this era of evidence based medicine, the researchers aim to investigate whether treatment with progesterone for patients with first trimester vaginal bleeding will alter the rates of obstetrical complications and adverse pregnancy outcomes. The researchers hypothesize that treatment with progesterone for first trimester vaginal bleeding will alter the rates of the above mentioned obstetrical complications and adverse pregnancy outcomes.

Official Title
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The Impact of Progesterone Treatment on Obstetrical Outcome Among Women With First Trimester Vaginal Bleeding

Conditions
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Threatened Abortion, Pre-Eclampsia, Abruptio Placentae, Fetal Growth Retardation, Premature Birth

Intervention / Treatment
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* Drug: dihydroxyprogesterone caproate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone<br>Women attending the Gynecological Emergency Unit due to first trimester vaginal bleeding, with a viable singleton pregnancy at a gestational age of 6-13 completed weeks of gestation | Drug: dihydroxyprogesterone caproate<br>* 250mg once a week by intramuscular administration<br>* Other names: 17a-Hydroxyprogesterone caproate;|
| Placebo Comparator: Placebo<br>Women attending the Gynecological Emergency Unit due to first trimester vaginal bleeding, with a viable singleton pregnancy at a gestational age of 6-13 completed weeks of gestation. | Drug: Placebo<br>* 0.9% NaCl<br>* Other names: Sailine, Physiological water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature Birth, Threatened Abortion, Progesterone, Subchorionic Hematoma, Pre-Eclampsia, Abruptio Placentae, Fetal Growth Retardation