Uterine Electrical Activity Before and After Progesterone Treatment for Preterm Labor

NCT01406197 | Withdrawn

• 1 other identifier: IRB#10OB059
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects of various formulations of progesterone on uterine electromyographic (EMG) activity in pregnant patients in premature labor to determine if progesterone will suppress uterine electrical activity and which formulation may be best for inhibition of uterine activity. Patients will be monitored prior to treatment and following treatment (every 2 to 4 hours) with one of three different formulations of progesterone for up to two days. Patients will continue to be observed until they deliver. Comparisons will be for uterine EMG activity from before treatment to that following treatments at 2, 4, 8, 12 24 and 48 hours and times of delivery after treatments (hours or days following treatments). Comparisons between mean values for EMG activity between the various treatments at the various times will also be made.

Conditions

Preterm Labor

Keywords

Progesterone; Progestins; Preterm labor; Premature birth; Uterine electromyography; Uterine contractility

Outcome Measures

Primary Outcomes (1)

• Inhibition of uterine electromyographic (EMG) activity by various formulations of progesterone.

  Uterine electrical activity will be recorded (for 30 minutes at each time point) from the abdominal surface of pregnant patients before (30 minutes before treatment) and following treatment (at 2, 4, 8, 12, 24 and up to 48 hours) with either vehicles or progesterone treatments to evaluate if the treatments reduce EMG activity and therefore may be potential candidates for possible interventions for treating a preterm labor.

  EMG will be measured at various times including 0 time pretreatment and up to 48 hours after treatments

Secondary Outcomes (1)

• Effects of progesterone on uterine EMG activity and preterm birth

  Various times after treatments up to 16 weeks to determine when the patients deliver

Study Arms (3)

Vaginal progesterone

EXPERIMENTAL

vaginal 150 mg micronized progesterone cream delivered via a vaginal applicator; dosed daily (Prochieve, Columbia Laboratories)

Drug: Experimental: Vaginal progesterone

Topical progesterone

EXPERIMENTAL

topical 150 mg micronized progesterone gel applied to abdomen via a novel applicator; dosed daily

Drug: Experimental: Topical progesterone

Intramuscular progesterone

EXPERIMENTAL

injected IM (upper arm or thigh via syringe) 50mg/day micronized progesterone (Watson Pharmaceuticals)

Drug: Experimental: Intramuscular progesterone

Interventions

Experimental: Vaginal progesterone DRUG

Vaginal progesterone formulation (150 mg micronized progesterone daily)

Also known as: Prochieve, Columbia Laboratories

Vaginal progesterone

Experimental: Topical progesterone DRUG

Progesterone will be applied daily (150 mg micronized progesterone)by topical application

Also known as: No other name available

Topical progesterone

Experimental: Intramuscular progesterone DRUG

Preterm labor patients will be injected IM with micronized progesterone (50 mg/day).

Also known as: Watson Laboratories

Intramuscular progesterone

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy patients in preterm labor between 24 to 34 weeks of gestation presenting to St. Joseph's Hospital and Medical Center.
• Preterm labor is defined as at least 6 contractions in 60 minutes with a cervix either dilated to 2 centimeters or effaced to 80% and a cervical length measured by ultrasound of less than 3 centimeters, and a positive fetal fibronectin.
• Maternal ages will be within 17 to 40 year-old range.

You may not qualify if:

• Patients with preterm premature rupture of membranes (PPROM) will be excluded from the study, due to possibility of ascending infection, as will those patients with suspected chorioamnionitis.
• Patients with medical conditions that contraindicate tocolysis, such as non-reassuring fetal heart tracings, will also be excluded.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Related Publications (5)

• Kuon RJ, Shi SQ, Maul H, Sohn C, Balducci J, Maner WL, Garfield RE. Pharmacologic actions of progestins to inhibit cervical ripening and prevent delivery depend on their properties, the route of administration, and the vehicle. Am J Obstet Gynecol. 2010 May;202(5):455.e1-9. doi: 10.1016/j.ajog.2010.03.025.

  PMID: 20452487 BACKGROUND

• Lucovnik M, Kuon RJ, Chambliss LR, Maner WL, Shi SQ, Shi L, Balducci J, Garfield RE. Use of uterine electromyography to diagnose term and preterm labor. Acta Obstet Gynecol Scand. 2011 Feb;90(2):150-7. doi: 10.1111/j.1600-0412.2010.01031.x. Epub 2010 Dec 7.

  PMID: 21241260 BACKGROUND

• Kuon RJ, Shi SQ, Maul H, Sohn C, Balducci J, Shi L, Garfield RE. A novel optical method to assess cervical changes during pregnancy and use to evaluate the effects of progestins on term and preterm labor. Am J Obstet Gynecol. 2011 Jul;205(1):82.e15-20. doi: 10.1016/j.ajog.2011.02.048. Epub 2011 Feb 23.

  PMID: 21497789 BACKGROUND

• Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.

  PMID: 21472815 BACKGROUND

• Ruddock NK, Shi SQ, Jain S, Moore G, Hankins GD, Romero R, Garfield RE. Progesterone, but not 17-alpha-hydroxyprogesterone caproate, inhibits human myometrial contractions. Am J Obstet Gynecol. 2008 Oct;199(4):391.e1-7. doi: 10.1016/j.ajog.2008.06.085.

  PMID: 18928984 BACKGROUND

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• James Balducci, MD

  St. Joseph's Hospital and Medical Center, Phoenix

  PRINCIPAL INVESTIGATOR

• Robert Garfield, PhD

  St. Joseph's Hospital and Medical Center, Phoenix

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: August 1, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

US (1)