Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor

Preterm Labor Clinical Trial

Official title:

Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02430233
• Other study ID #: 0080-13
• Status: Completed
• Phase: Phase 4
• Start date: December 19, 2018
• Est. completion date: February 27, 2023

Study information

• Verified date: February 2023
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.

Description:

Since progesterone derivatives are useful in preventing preterm labor in cases of risk factors or previous preterm labor, we hypothesize that they will also show efficacy in pregnancy prolongation in women whose preterm labor was arrested following tocolytic treatment.

Patients diagnosed with arrested pre-term labor following tocolytics at 24-34 gestational weeks will be randomly allocated to receive either vaginal micronized progesterone 400 mg/day or no treatment.

This study has the potential to find a treatment to prevent preterm labor and thus to reduce neonatal morbidity and mortality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age

2. Tocolytic treatment between 24+0 and 34+0 weeks

3. Patient's consent to participate in this study

4. 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment

5. Arrest of preterm labor

Exclusion Criteria

1. Contraindication to ongoing pregnancy including:

1. Suspected amnionitis during testing for eligibility- evidence of active infection including temperature = 38.0°C and uterine tenderness, foul-smelling vaginal discharge, maternal tachycardia of 120 beats per minute or greater, or sustained fetal tachycardia of 160 beats per minute or greater

2. Evidence of significant placental abruption (contractions and significant bleeding from placental origin)

3. Intrauterine fetal death diagnosed at the time of admission

2. Major fetal malformation

3. Known maternal allergy to progesterone

4. Current use of progesterone at the time of admission

5. Epilepsy

6. Breast cancer

7. PPROM (preterm premature rupture of membranes) during testing for eligibility

8. Age below 18 years

9. Known active liver disease (elevated liver enzymes at twice the upper normal limit according to medical history or blood test that were taking doring standard medical care)

10. History of deep vein thrombosis

11. Major active psychiatric disorders (major affective disorders and psychotic disorders)

12. Uncontrolled chronic hypertension

13. Heart failure

14. Chronic renal failure

15. Pre-gestational diabetes with known target organ damage

16. History of spontaneous preterm delivery

17. Previous tocolytic treatment during the current pregnancy

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Preterm Labor

Intervention

Drug:
• micronized progesterone 400 mg (Utrogestan)
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)

Locations

Country	Name	City	State
Israel	Emek Medical center	Afula	Please Select
Israel	Assuta Ashdod medical center	Ashdod
Israel	Poriya Medical Center	Tiberias	North

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean number of days from enrollment to delivery		Up to 18 weeks
Primary	The rate of preterm spontaneous delivery	defined as spontaneous labor or preterm delivery following induction/cesarean section due to preterm premature rupture of membranes prior to 37 weeks of gestation	Up to 13 weeks
Secondary	Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation		Up to 13 weeks
Secondary	Pregnancy prolongation beyond one week		Up to 18 weeks
Secondary	Need for repeated acute tocolysis		Up to 13 weeks
Secondary	Number of hospitalizations and length of stay until 36.6 gestational weeks		Up to 13 weeks
Secondary	The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)		Up to 13 weeks
Secondary	Admission to the NICU (neonatal intensive care unit)		From delivery and up to 28 days
Secondary	Length of NICU stay		From delivery and up to 3 months
Secondary	Length of neonate hospital stay		From delivery and up to 3 months
Secondary	Fetal/neonatal death		Around delivery
Secondary	Birth weight and the rate of small for gestational age neonates		Around delivery
Secondary	The rate of neonatal complications	including transient tachypnea, RDS (respiratory distress syndrome), bronchopulmonary dysplasia, ventilatory support, supplemental oxygen, IVH (intraventricular hemorrhage), NEC (necrotizing enterocolitis), PDA (patent ductus arteriosus), retinopathy, neonatal sepsis, and congenital abnormalities not previously identified (specifically genital abnormalities).	From delivery and up to 3 months
Secondary	The rate of chorioamnionitis and endometritis		around delivery and up to 1 week post-partum
Secondary	Adverse medication reactions		Up to 13 weeks
Secondary	Postpartum hemorrhage		From delivery and up to 1 week post-partum
Secondary	Revision of uterine and cervix and reasons for the procedure		During the 48 hours from delivery
Secondary	Urinary tract or vulvovaginal infection until 36.6 weeks		Up to 13 weeks