Early Onset of Delivery Before 37 WeeksPhase 4PESAPRONCT01643980
Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies
A Phase 4 study testing Vaginal micronized progesterone and Cervical pessary in people with Early Onset of Delivery Before 37 Weeks, run by Dra.Cristina Martinez Payo at 27 sites in Spain.
Trial summary
The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Onset of Delivery Before 37 Weeks
- What is being tested?
- Vaginal micronized progesterone and Cervical pessary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 27 sitesSpain
- Study dates
- Aug 2012to Apr 2016
- 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
- Pregnant women with short cervix (=< 25 mm) identified by use of routine transvaginal ultrasonography at 19-22 weeks of gestation.
- Single pregnancy
- Women older than 18 year-old
- Women sign informed consent according GCP and local legislation
- Gestational age at randomization between 20+1 and 23+6 weeks.
Who cannot join
- Major fetal abnormalities
- Major uterine abnormalities
- Placenta praevia during current pregnancy
- Vaginal bleeding or ruptured membranes in the moment of randomization
- Cervical cerclage in situ
- History of cone biopsy
Show all 12Show fewer
- Allergic to peanuts
- Contraindication for Progesterone usage.
- Active treatment with Progesterone at randomization.
- History of 3 or more premature labor.
- If in the investigator's opinion, there are findings on physical examination, abnormalities in the results of clinical analyzes or other medical factors, social or psycho-social that could negatively influence.
- Women unable to give the informed consent
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Spain27 sites
University Hospital Príncipe de Asturias
Alcalá de Henarés, Madrid, 28805
University Hospital Fundación de Alcorcón
Alcorcón, Madrid, 28922
University Hospital Quiron Dexeus
Barcelona, Barcelona, 08028
University Hospital Madrid Monte Principe
Boadilla del Monte, Madrid, 28660
Burgos University Hospital
Burgos, Burgos, 09006
Ciudad Real General University Hospital
Ciudad Real, Ciudad Real, 13005
Hospital Universitario de Donostia
Donostia / San Sebastian, San Sebastian, 20080
University Hospital Fuenlabrada
Fuenlabrada, Madrid, 28942
University Hospital de Getafe
Getafe, Madrid, 28905
Palamos Hospital
Girona, Palamos, 17320
Guadalajara General University Hospital
Guadalajara, Guadalajara, 19002
Igualada Hospital
Igualada, Barcelona, 08700
University Hospital Severo Ochoa
Leganés, Madrid, 28911
University Hospital de León
León, León, 24071
Sanitas La Zarzuela Hospital
Madrid, Madrid, 28023
University Hospital Ramón y Cajal
Madrid, Madrid, 28046
Sanitas La Moraleja Hospital
Madrid, Madrid, 28050
University Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
University Hospital Quirón Málaga
Málaga, Málaga, 29004
University Hospital Rey Juan Carlos I
Móstoles, Madrid, 28933
University Hospital Mostoles
Móstoles, Madrid, 28935
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702
University Hospital San Juan de Alicante
Sant Joan d'Alacant, Alicante, 03550
Hospital Infanta Elena
Valdemoro, Madrid, 28040
Valladolid Clinic Universitary Hospital
Valladolid, Valladolid, 47005
University Hospital Rio Hortega
Valladolid, Valladolid, 47012
University Hospital Miguel Servet
Zaragoza, Zaragoza, 50009
About this study
The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. The investigators propose a clinical trial with the objective to identify effective strategies to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy.
The investigators intend to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy to apply, and they present very few maternal-fetal secondary effects.
Read the detailed description
The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. Since 1990, many published articles describe the sonographic measurement of the cervix from the week 16 as method of population screening to detect women at risk. Several studies provide evidence about an inverse relationship between the cervical length and the risk of preterm delivery. For this reason, if there is an effective intervention for patients with cervix short (about < 25mm), made this measure in the middle of the second term, the investigators could reduce the prematurity. Regarding possible therapeutic strategies, recent published data demonstrate the effective of vaginal progesterone and cervical pessary in this population. However, both treatments have never been compared and none of the two strategies are indicated in this population. Therefore it results necessary to compare both treatments in order to establish clinical recommendations. The investigators propose a clinical trial to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries in order to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy.
- Conditions
- Early Onset of Delivery Before 37 Weeks
- Being tested
- Vaginal micronized progesterone, Cervical pessary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal micronized progesteroneDrug
200 mg vaginal route per day
Cervical pessaryDevice
Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm)
| Study group | Role | What they receive |
|---|---|---|
| Vaginal micronized progesterone | Experimental | 200 mg vaginal route per day Receives: Drug: Vaginal micronized progesterone |
| Cervical pessary | Active comparator | Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm) Receives: Device: Cervical pessary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of spontaneous preterm birth before 34 weeks of gestation
Measured: up to 11 weeks (from date of randomization until delivery)
Secondary outcomes (10)
Proportion of spontaneous preterm birth before 37 weeks of gestation
Measured: up to 17 weeks (from date of randomization until delivery)
Proportion of Spontaneous preterm birth before 28 weeks of gestation
Measured: up to 8 weeks (from date of randomization until delivery)
Rate of premature rupture of membranes before 34 weeks of gestation
Measured: up to 11 weeks (from date of randomization until delivery)
Weight at birth
Measured: up to 21 weeks (from date of randomization until delivery)
Rate of fetal and neonatal mortality
Measured: From date of randomization until the date of delivery, assessed up 21 weeks
Symptomatic vaginal infections during treatment period
Measured: From date of randomization until the date of delivery, assessed up 21 weeks
Proportion of participants with adverse events
Measured: From date of randomization until the date of delivery, assessed up 21 weeks
Rate of Chorioamnionitis during third term
Measured: From date of randomization until the date of delivery, assessed up 21 weeks
Need of admission because of premature labor before 34 weeks of gestation
Measured: up to 14 weeks (from date of randomization until delivery)
Rate of neonatal morbidity
Measured: From date of randomization until the date of delivery, assessed up 21 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Onset of Delivery Before 37 WeeksStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dra.Cristina Martinez Payo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dra.Cristina Martinez Payo, Puerta de Hierro University Hospital
- Investigators
- Sara Cruz Melguizo, Dr, Principal investigator, University Hospital Puerta de Hierro MajadahondaCristina Martinez Payo, Dr., Principal investigator, University Hospital Puerta de Hierro Majadahonda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643980
- Sponsor's protocol ID
- PESAPRO-2012
- Other IDs
- 2012-000241-13
- Acronym
- PESAPRO
- Status last verified
- Oct 2016
- First submitted
- 12 Jun 2012
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cruz-Melguizo S, San-Frutos L, Martinez-Payo C, Ruiz-Antoran B, Adiego-Burgos B, Campillos-Maza JM, Garcia-Gonzalez C, Martinez-Guisasola J, Perez-Carbajo E, Teulon-Gonzalez M, Avendano-Sola C, Perez-Medina T. Cervical Pessary Compared With Vaginal Progesterone for Preventing Early Preterm Birth: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):907-915. doi: 10.1097/AOG.0000000000002884.
PubMed 30204689Cabrera-Garcia L, Cruz-Melguizo S, Ruiz-Antoran B, Torres F, Velasco A, Martinez-Payo C, Avendano-Sola C; PESAPRO trial Group. Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:427. doi: 10.1186/s13063-015-0964-y.
PubMed 26407852
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Preterm Birth in Pregnant Women at Risk Identified by Ultrasound: Evaluation of Two Treatment Strategies
- ClinicalTrials.gov ID
- NCT01643980
- Acronym / sponsor ID
- PESAPRO / PESAPRO-2012
- Conditions
- Early Onset of Delivery Before 37 Weeks
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Dra.Cristina Martinez PayoUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Jul 2012 (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.
The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. The investigators propose a clinical trial with the objective to identify effective strategies to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy.
The investigators intend to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries. These 2 strategies are affordable, easy to apply, and they present very few maternal-fetal secondary effects.
Detailed description
The preterm birth is considered as a main problem in the modern obstetrics, being the responsible of greatest of 50% neonatal morbimortality and heavy costs. Despite the significant medical advances, the rate of prematurity has not declined over the past 40 years and even continues to rise in the developed countries. In order to decrease the prematurity is necessary that two premises: to identify the pregnant women at risk of preterm birth, and dispose of useful measures aimed at prolonging the pregnancy and therefore avoid preterm delivery. Since 1990, many published articles describe the sonographic measurement of the cervix from the week 16 as method of population screening to detect women at risk. Several studies provide evidence about an inverse relationship between the cervical length and the risk of preterm delivery. For this reason, if there is an effective intervention for patients with cervix short (about < 25mm), made this measure in the middle of the second term, the investigators could reduce the prematurity. Regarding possible therapeutic strategies, recent published data demonstrate the effective of vaginal progesterone and cervical pessary in this population. However, both treatments have never been compared and none of the two strategies are indicated in this population. Therefore it results necessary to compare both treatments in order to establish clinical recommendations. The investigators propose a clinical trial to compare two accepted strategies: administration of progesterone (vaginally) or the placement of vaginal pessaries in order to reduce the premature birth (34 weeks and earlier) rate in the population of pregnant women at risk for premature birth, which will be identified by ultrasound during the second trimester of their pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal micronized progesterone | Experimental | Drug: Vaginal micronized progesterone200 mg vaginal route per day |
| Cervical pessary | Active comparator | Device: Cervical pessaryCervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm) |
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)
- Pregnant women with short cervix (=< 25 mm) identified by use of routine transvaginal ultrasonography at 19-22 weeks of gestation.
- Single pregnancy
- Women older than 18 year-old
- Women sign informed consent according GCP and local legislation
- Gestational age at randomization between 20+1 and 23+6 weeks.
Key exclusion criteria (12 listed)
- Major fetal abnormalities
- Major uterine abnormalities
- Placenta praevia during current pregnancy
- Vaginal bleeding or ruptured membranes in the moment of randomization
- Cervical cerclage in situ
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 |
|---|---|---|
| Vaginal micronized progesterone200 mg vaginal route per day | Drug | Vaginal micronized progesterone |
| Cervical pessaryCervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm) | Device | Cervical pessary |
Primary outcome
Proportion of spontaneous preterm birth before 34 weeks of gestation
Time frame: up to 11 weeks (from date of randomization until delivery)
10 secondary outcomes
Proportion of spontaneous preterm birth before 37 weeks of gestation
Time frame: up to 17 weeks (from date of randomization until delivery)
Proportion of Spontaneous preterm birth before 28 weeks of gestation
Time frame: up to 8 weeks (from date of randomization until delivery)
Rate of premature rupture of membranes before 34 weeks of gestation
Time frame: up to 11 weeks (from date of randomization until delivery)
Weight at birth
Time frame: up to 21 weeks (from date of randomization until delivery)
Rate of fetal and neonatal mortality
Time frame: From date of randomization until the date of delivery, assessed up 21 weeks
Symptomatic vaginal infections during treatment period
Time frame: From date of randomization until the date of delivery, assessed up 21 weeks
Proportion of participants with adverse events
Time frame: From date of randomization until the date of delivery, assessed up 21 weeks
Rate of Chorioamnionitis during third term
Time frame: From date of randomization until the date of delivery, assessed up 21 weeks
Need of admission because of premature labor before 34 weeks of gestation
Time frame: up to 14 weeks (from date of randomization until delivery)
Rate of neonatal morbidity
Time frame: From date of randomization until the date of delivery, assessed up 21 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 17 Oct 2016.
- Derived from this study: PubMed 30204689Cruz-Melguizo S, San-Frutos L, Martinez-Payo C, Ruiz-Antoran B, Adiego-Burgos B, Campillos-Maza JM, Garcia-Gonzalez C, Martinez-Guisasola J, Perez-Carbajo E, Teulon-Gonzalez M, Avendano-Sola C, Perez-Medina T. Cervical Pessary Compared With Vaginal Progesterone for Preventing Early Preterm Birth: A Randomized Controlled Trial. Obstet Gynecol. 2018 Oct;132(4):907-915. doi: 10.1097/AOG.0000000000002884.
- Derived from this study: PubMed 26407852Cabrera-Garcia L, Cruz-Melguizo S, Ruiz-Antoran B, Torres F, Velasco A, Martinez-Payo C, Avendano-Sola C; PESAPRO trial Group. Evaluation of two treatment strategies for the prevention of preterm birth in women identified as at risk by ultrasound (PESAPRO Trial): study protocol for a randomized controlled trial. Trials. 2015 Sep 25;16:427. doi: 10.1186/s13063-015-0964-y.
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.
Sara Cruz Melguizo, Dr principal investigator
University Hospital Puerta de Hierro Majadahonda
Cristina Martinez Payo, Dr. principal investigator
University Hospital Puerta de Hierro Majadahonda
27 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 Vaginal micronized progesterone and Cervical pessary in people with Early Onset of Delivery Before 37 Weeks, run by Dra.Cristina Martinez Payo at 27 sites in Spain.
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 12 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Spain. 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?
Proportion of spontaneous preterm birth before 34 weeks of gestation (time frame: up to 11 weeks (from date of randomization until delivery)). 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 NCT01643980, which also lists 2 linked publications.
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 17 Oct 2016.