Not provided
Not provided
Not provided
Not provided
Difficulty with endometrial sample collection. New study design to be prospective observational to validate reliable methods of endometrial sampling at time of c-section.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
The objective of this pilot study is to evaluate the local pharmacokinetics of progesterone in pregnancy through evaluation of progesterone levels in maternal serum, endometrium, and cordblood in pregnant patients undergoing scheduled cesarean delivery.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal progesterone | Active Comparator | 200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery |
|
| Control | No Intervention | No intervention, scheduled cesarean delivery |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micronized Progesterone | Drug | 200mg micronized progesterone placed vaginally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial (ng/mg) progesterone time/concentration profile | Concentration of progesterone in endometrium, sampled at time of scheduled c-section | 12 hours |
| Plasma (ng/ml) progesterone time/concentration profile | concentration of serum progesterone, sampled at time of scheduled c-section | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Side effect survey | survey of side effects | 24hr after delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Contraindication to vaginal progesterone suppository
Bleeding disorder (such as thrombophilia)
Use of 17-hydroxyprogesterone caproate in the pregnancy
Use of vaginal progesterone in the pregnancy
History of adverse reaction to progesterone
Current vaginitis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
IPD may be requested following trial completion and publication with appropriate data sharing agreement.
Following trial completion and publication
Data sharing agreement
Not provided
Not provided
| ID | Term |
|---|---|
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Randomized controlled trial
Not provided
Not provided
Not provided
Not provided
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |