Preterm Birth Clinical Trial
Official title:
A Comparison of Intramuscular and Subcutaneous Administration of 17-hydroxyprogesterone Caproate (17-OHPC) in Pregnancy
NCT number | NCT04183452 |
Other study ID # | STUDY19110111 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | June 16, 2020 |
Est. completion date | April 6, 2023 |
Verified date | August 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study will compare the plasma concentration x time curve or Area Under the Curve (AUC) and the side effects reported with 250 mg intramuscular (IM) and 275 mg subcutaneous (SC) injections of 17-hydroxyprogesterone caproate (17-OHPC).
Status | Terminated |
Enrollment | 24 |
Est. completion date | April 6, 2023 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Pregnant female with documented prior birth between 16 0/7- 36 6/7 week gestation from spontaneous preterm labor or preterm premature rupture of membranes 2. Gestational age (GA) < 22 weeks, based on study determined GA (as treatment must start between 16 0/7 and 21 6/7 weeks) 3. Singleton gestation 4. Age between 18 - 45 years 5. Able to give informed consent and undergo all study procedures including a single seven day pharmacokinetic study which requires daily venipunctures and willingness to answer questions about side effects and discomfort at each study visit. Exclusion Criteria: 1. Known major fetal anomaly or chromosomal anomalies that might affect gestational age at delivery 2. Malformation of uterus (uterine didelphus, septate uterus or bicornuate uterus) 3. Medical or obstetrical complication that might affect gestational age at delivery, such as active ulcerative colitis, liver tumors, liver disease/failure, renal disease/failure, undiagnosed vaginal bleeding unrelated to pregnancy, or hypertension requiring 2 or more agents 4. Current or history of thrombosis or thromboembolic disorders 5. Known or suspected breast cancer, other hormone-sensitive cancer, or a history of these conditions 6. Moderately severe depression (Patient Health Questionnaire-9 (PHQ-9) score =15, Edinburgh Postnatal Depression Scale (EPDS) score of >13, or suicidal ideation) |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | Christiana Care | Newark | Delaware |
United States | University of Pittsburgh-Magee Womens Hospital | Pittsburgh | Pennsylvania |
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Steve N. Caritis, MD | AMAG Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare the plasma concentration x time curve or the Area Under the Curve (AUC) of the 275 mg subcutaneous dose of 17-OHPC to the 250 mg intramuscular dose of 17-OHPC | Evaluate the difference between the plasma concentration x time curve or the Area Under the Curve (AUC) at steady state between the 250 mg dose of 17-OHPC administered intramuscularly and the 275 mg dose of 17-OHPC administered subcutaneously with an autoinjector. | 9 weeks after initiation (26-30 weeks gestation) | |
Primary | Compare the severity of injection related side effects of the intramuscular and subcutaneous routes of administration of 17-OHPC | Participants will complete a Visual Analog Scale (VAS) with each injection that grades the severity of injection related side effects as none, mild, moderate or severe. This data will be used to compare the side effects of the intramuscular injections to the subcutaneous injections. | from study initiation until 36 weeks of pregnancy or delivery | |
Primary | Compare the level of injection related discomfort of the intramuscular and subcutaneous routes of administration of 17-OHPC | Participants will complete a Visual Analog Scale (VAS) with each injection that grades the level of discomfort associated with the injection as none, mild, moderate or severe. This data will be used to compare the level of discomfort of the intramuscular injections to the subcutaneous injections. | from study initiation until 36 weeks of pregnancy or delivery |
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