Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

Premature Birth Clinical Trial

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Official title:

Vaginal Versus Intramuscular Progesterone for the Prevention of Recurrent Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02913495
• Other study ID #: 16D.542
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: September 2021

Study information

• Verified date: October 2021
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the two suggested therapies for prevention of recurrent preterm birth (PTB) in women with a prior spontaneous preterm birth, vaginal and intramuscular progesterone to determine whether vaginal progesterone is superior to intramuscular progesterone in the prevention of recurrent preterm birth.

Description:

Preterm birth is one of the leading causes of neonatal morbidity and mortality. One of the greatest predictors of preterm birth is a history of prior spontaneous preterm birth. Presently 17 hydroxyprogesterone caproate (intramuscular) is the only FDA approved product for the prevention of recurrent preterm birth, however recent studies suggest that vaginal progesterone may be used for this purpose, and may even be superior. The American College of Obstetrics and Gynecology does not specify the optimal route of progesterone administration for the prevention of recurrent preterm birth. It is our intention to compare vaginal and intramuscular progesterone to see if one is superior.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women with singleton pregnancies
• =18 years old
• Estimated gestational age less than 24 0/7 weeks
• Prior spontaneous preterm birth of a singleton pregnancy between 16 0/7-36 6/7 weeks.
• Patients are also required provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

Exclusion Criteria:

• History of an adverse reaction to progesterone;
• A contraindication to progesterone treatment;
• Placenta previa or accreta;
• Major fetal anomaly diagnosed on ultrasound or known chromosomal disorder;
• Multifetal gestation;
• Preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment

Related Conditions & MeSH terms

• Premature Birth

Intervention

Drug:
• Vaginal Progesterone

• Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Baystate Medical Center	Springfield	Massachusetts
United States	George Washington University	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Thomas Jefferson University	Baystate Medical Center, George Washington University, Ohio State University, Vriginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Committee on Practice Bulletins-Obstetrics, The American College of Obstetricians and Gynecologists. Practice bulletin no. 130: prediction and prevention of preterm birth. Obstet Gynecol. 2012 Oct;120(4):964-73. — View Citation

Saccone G, Khalifeh A, Elimian A, Bahrami E, Chaman-Ara K, Bahrami MA, Berghella V. Vaginal progesterone vs intramuscular 17a-hydroxyprogesterone caproate for prevention of recurrent spontaneous preterm birth in singleton gestations: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Mar;49(3):315-321. doi: 10.1002/uog.17245. Epub 2017 Feb 6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm birth <37 weeks	Incidence of gestational age of delivery less than 37 weeks	up to 9 months (delivery)
Secondary	Gestational age of delivery		up to 9 months (delivery)
Secondary	Preterm birth <34 weeks and <28 weeks		up to 9 months (delivery)
Secondary	Second trimester cervical length <25mm		2 months
Secondary	Mode of delivery	Delivery mode- vaginal, cesarean, operative vaginal	up to 9 months (delivery)
Secondary	Maternal mortality		up to 9 months (delivery)
Secondary	5 minute Apgar score		up to 9 months (delivery)
Secondary	Neonatal intensive care unit admission		up to 9 months (delivery)
Secondary	Composite neonatal morbidity	(respiratory distress syndrome, grade III or IV intraventricular hemorrhage, culture proven sepsis, neonatal enterocolitis, and perinatal mortality up to 28 days of life)	up to 9 months (delivery)
Secondary	Birthweight		up to 9 months (delivery)
Secondary	Perinatal mortality up to 28 days of life		up to 10 months (4 weeks after delivery)
Secondary	Medication side effects		up to 9 months (delivery)
Secondary	Satisfaction with medication (5 point Likert scale)		up to 9 months (delivery)
Secondary	Medication adherence	Vaginal progesterone: Overall adherence: #days used/#days of treatment x 100; Non-adherent: =4 days between doses; Intramuscular progesterone: Overall adherence: #weeks used/#weeks of treatment x 100; Non-adherent: =10 days between doses	up to 9 months (delivery)
Secondary	Planned subgroup analysis for the outcome preterm birth <37 weeks, <34 weeks, <28 weeks	Planned subgroup analysis for the primary outcome as well as the secondary outcomes of preterm birth <34 weeks and <28 weeks of patients with a cervical length <25mm versus =25mm, history-indicated cerclage versus not, and for those started on progesterone 16-20 weeks versus 20-24 weeks.	up to 9 months (delivery)