Preterm LaborPhase 4NCT02430233
Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor
A Phase 4 study testing micronized progesterone 400 mg (Utrogestan) in people with Preterm Labor, run by HaEmek Medical Center, Israel at 3 sites in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- micronized progesterone 400 mg (Utrogestan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 3 sitesIsrael
- Study dates
- 19 Dec 2018to 27 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age
- Tocolytic treatment between 24+0 and 34+0 weeks
- Patient's consent to participate in this study
- 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
- Arrest of preterm labor
Who cannot join
- Contraindication to ongoing pregnancy including:
- 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
- Evidence of significant placental abruption (contractions and significant bleeding from placental origin)
- Intrauterine fetal death diagnosed at the time of admission
- Major fetal malformation
- Known maternal allergy to progesterone
Show all 20Show fewer
- Current use of progesterone at the time of admission
- Epilepsy
- Breast cancer
- PPROM (preterm premature rupture of membranes) during testing for eligibility
- Age below 18 years
- 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)
- History of deep vein thrombosis
- Major active psychiatric disorders (major affective disorders and psychotic disorders)
- Uncontrolled chronic hypertension
- Heart failure
- Chronic renal failure
- Pre-gestational diabetes with known target organ damage
- History of spontaneous preterm delivery
- Previous tocolytic treatment during the current pregnancy
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Emek Medical center
Afula, Please Select, 18100
Assuta Ashdod medical center
Ashdod
Poriya Medical Center
Tiberias, North, 15208
About this study
Official title: Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial
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.
Read the detailed 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.
- Conditions
- Preterm Labor
- Being tested
- micronized progesterone 400 mg (Utrogestan)
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micronized progesterone 400 mg (Utrogestan)Drug
Also called Utrogestan- 200mg×2 PV(per vagina) per day
participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
| Study group | Role | What they receive |
|---|---|---|
| micronized progesterone 400 mg | Experimental | participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day) Receives: Drug: micronized progesterone 400 mg (Utrogestan) |
| No treatment | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean number of days from enrollment to delivery
Measured: Up to 18 weeks
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
Measured: Up to 13 weeks
Secondary outcomes (16)
Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation
Measured: Up to 13 weeks
Pregnancy prolongation beyond one week
Measured: Up to 18 weeks
Need for repeated acute tocolysis
Measured: Up to 13 weeks
Number of hospitalizations and length of stay until 36.6 gestational weeks
Measured: Up to 13 weeks
The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)
Measured: Up to 13 weeks
Admission to the NICU (neonatal intensive care unit)
Measured: From delivery and up to 28 days
Length of NICU stay
Measured: From delivery and up to 3 months
Length of neonate hospital stay
Measured: From delivery and up to 3 months
Fetal/neonatal death
Measured: Around delivery
Birth weight and the rate of small for gestational age neonates
Measured: Around delivery
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).
Measured: From delivery and up to 3 months
The rate of chorioamnionitis and endometritis
Measured: around delivery and up to 1 week post-partum
Adverse medication reactions
Measured: Up to 13 weeks
Postpartum hemorrhage
Measured: From delivery and up to 1 week post-partum
Revision of uterine and cervix and reasons for the procedure
Measured: During the 48 hours from delivery
Urinary tract or vulvovaginal infection until 36.6 weeks
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study start19 Dec 2018
- Primary completion27 Feb 2023
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zohar Nachum, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430233
- Sponsor's protocol ID
- 0080-13
- Status last verified
- Feb 2023
- First submitted
- 20 Apr 2015
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nachum Z, Ganor Paz Y, Massalha M, Wated M, Harel N, Yefet E. Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419894. doi: 10.1001/jamanetworkopen.2024.19894.
PubMed 38976270
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Progesterone for the Prolongation of Pregnancy After Arrested Pre-term Labor - Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02430233
- Acronym / sponsor ID
- 0080-13
- Conditions
- Preterm Labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 27 Feb 2023 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| micronized progesterone 400 mg | Experimental | Drug: micronized progesterone 400 mg (Utrogestan)participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day) |
| No treatment | No intervention | –No treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years of age
- Tocolytic treatment between 24+0 and 34+0 weeks
- Patient's consent to participate in this study
- 24 hours after tocolytic initiation and up to 3 days after finishing the tocolytic treatment
- Arrest of preterm labor
Key exclusion criteria (20 listed)
- Contraindication to ongoing pregnancy including:
- Major fetal malformation
- Known maternal allergy to progesterone
- Current use of progesterone at the time of admission
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| micronized progesterone 400 mg (Utrogestan)Also: Utrogestan- 200mg×2 PV(per vagina) per dayparticipants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day) | Drug | micronized progesterone 400 mg |
Primary outcome
The mean number of days from enrollment to delivery
Time frame: Up to 18 weeks
The rate of preterm spontaneous delivery
Time frame: Up to 13 weeks
defined as spontaneous labor or preterm delivery following induction/cesarean section due to preterm premature rupture of membranes prior to 37 weeks of gestation
16 secondary outcomes
Number of days from recruitment to repeated preterm labor episode or preterm premature rupture of membranes, up to 37 weeks of gestation
Time frame: Up to 13 weeks
Pregnancy prolongation beyond one week
Time frame: Up to 18 weeks
Need for repeated acute tocolysis
Time frame: Up to 13 weeks
Number of hospitalizations and length of stay until 36.6 gestational weeks
Time frame: Up to 13 weeks
The rate of preterm spontaneous labor (defined as spontaneous labor or preterm premature rupture of membranes prior to 37 weeks of gestation)
Time frame: Up to 13 weeks
Admission to the NICU (neonatal intensive care unit)
Time frame: From delivery and up to 28 days
Length of NICU stay
Time frame: From delivery and up to 3 months
Length of neonate hospital stay
Time frame: From delivery and up to 3 months
Fetal/neonatal death
Time frame: Around delivery
Birth weight and the rate of small for gestational age neonates
Time frame: Around delivery
The rate of neonatal complications
Time frame: From delivery and up to 3 months
The rate of chorioamnionitis and endometritis
Time frame: around delivery and up to 1 week post-partum
Adverse medication reactions
Time frame: Up to 13 weeks
Postpartum hemorrhage
Time frame: From delivery and up to 1 week post-partum
Revision of uterine and cervix and reasons for the procedure
Time frame: During the 48 hours from delivery
Urinary tract or vulvovaginal infection until 36.6 weeks
Time frame: Up to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 38976270Nachum Z, Ganor Paz Y, Massalha M, Wated M, Harel N, Yefet E. Vaginal Progesterone for Pregnancy Prolongation After Arrested Preterm Labor: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419894. doi: 10.1001/jamanetworkopen.2024.19894.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing micronized progesterone 400 mg (Utrogestan) in people with Preterm Labor, run by HaEmek Medical Center, Israel at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean number of days from enrollment to delivery (time frame: Up to 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.