Pharmacokinetics of Progesterone in Pregnancy-2 (PiP-2)

Thomas Jefferson University

Status and phase: Terminated; Phase 1

Conditions: Pregnancy Related

Treatments: Drug: micronized Progesterone

Study type: Interventional

Funder types: Other

Identifiers

NCT04753957

20D.1094

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3 patients

Sex: Female

Ages: 16 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥18yo
• Singleton gestation, ≥36 0/7 weeks gestation
• Scheduled cesarean delivery at Thomas Jefferson University Hospital or affiliate

Exclusion criteria

• Contraindication to vaginal progesterone suppository

  • Active hepatic disease
  • Prior or current thrombus
  • Known adverse reaction to progesterone
  • Peanut allergy

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

Vaginal progesterone

Active Comparator group

Description:

200mg micronized vaginal progesterone placed 7am prior to scheduled cesarean delivery

Treatment:

Drug: micronized Progesterone

Control

No Intervention group

Description:

No intervention, scheduled cesarean delivery