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The goal of this clinical trial] is to compare the outcomes between induction to labour at home versus hospitalized. The main questions it aims to answer are:
Researchers will compare both labour induction groups to see if the induction to labour at home has better outcomes as described previously.
INDOBAMHOS is a multicentric randomized clinical trial which is based in the principle that cervical rippening with intracervical probes with ballons is as safe as pharmacological induction with PGE2 and it seems to be a suitable option to develop the cervical rippening process of the induction at home rather than in the hospital.
The purpouse of the study is to demonstrate that the comfort of performing the cervical rippenning at home will benefit patients with an increase of the vaginal delivery rate and increases maternal satisfaction. And also will improve medical circuits and could be cost-effective when compared to hospitalized labour induction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| At home patients group | Experimental | After insertion of the Cervical Rippening Balloon and checking fetal and maternal well-being, the patient will go home between 6 and 8 hours to complete the cervical rippening process. The patient will remove autonomously the balloon and will go to the hospital one hour later, where the induction will continue. |
|
| Hospitalized patients group | Active Comparator | After the insertion of the Cervical Rippening Balloon and verifications of the fetal and materna well-being, the patient will undergo the cervical rippening process for between 6 and 8 hours in the hospital and will remain hospitalized until the time of the delivery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical rippening at home | Device | The experimental arm of the study will undergo cervical rippening at home between 6 and 8 hours and then will come back to the hospital to continue with the labor induction |
| Measure | Description | Time Frame |
|---|---|---|
| Type of delivery | Vaginal birth, Cesarean section | End of the delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Parity | Number of pregnancies and deliveries of each patient | At time of recruitment and end of delivery, about 1 or 2 days |
| Indication of induction | Cathegorical variable, it will be studied the different reason that motivated the induction to delivery for each patient |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal age | Years | At time of recruitment and end of delivery, about 1 or 2 days |
| Ethnicity | Cathegorical variable, it will be studied the different ethnicities of the patients |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria del Carmen Medina Mallén | Contact | 0034646337446 | mmedinam@santpau.cat | |
| Ignacio Montoro Pacha | Contact | 0034697596106 | imontorop@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Elisa Llurba Olivé | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Maria del Carmen Medina Mallén | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26719596 | Background | Rath W, Kehl S. The Renaissance of Transcervical Balloon Catheters for Cervical Ripening and Labour Induction. Geburtshilfe Frauenheilkd. 2015 Nov;75(11):1130-1139. doi: 10.1055/s-0035-1558094. |
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| Cervical rippening in the hospital | Device | The active comparator arm of the study will undergo cervical rippening in the hospital between 6 and 8 hours and then will remain there to continue with the labor induction |
|
| 1 day |
| Weeks of gestation | Measured in number of weeks and days | Only at time of recruitment, 1 day |
| Bishop score | Score obtained when evaluating the different features of the uterine cervix by touch | Before inserting the rippening balloon and after removing it, about 6 hours |
| Time of dilatation | Hours | During labour and until delivery, between 1 and 3 days |
| Time of cervical rippening balloon | Hours | At the insertion of the rippening balloon and after removing it, about 6 hours |
| Partian emptying of the balloon due to pain | Milliliters | During cervical rippening, about 6 hours |
| Pharmacological analgesia during the cervical rippening | Number of drugs administered | During cervical rippening, about 6 hours |
| Adverse outcomes | Number of adverse outcomes | During cervical rippening and labor, between 6 hours and 3 days |
| Artificial Amniorrhexis | Presence or absence | During cervical rippening and labor, between 6 hours and 3 days |
| Oxytocin infusion | Presence or absence | During cervical rippening and labor, between 6 hours and 3 days |
| Subsequent PGE2 use | Presence or absence | During cervical rippening and labor, between 6 hours and 3 days |
| Hyperstimulation | Presence or absence | During cervical rippening and labor, between 6 hours and 3 days |
| Type of delivery | Cathegorical variable, it will be studied the different type of delivery for each patient | At the moment of the delivery, between 1 day and 3 |
| Time to delivery | Hours | At the moment of the delivery, between 1 day and 3 |
| Reason for instrumentation | Cathegorical variable, it will be studied the different reason of instrumentation | At the moment of the delivery, between 1 day and 3 |
| Reason for Cesarean section | Cathegorical variable, it will be studied the different reason of cesarean section | At the moment of the delivery, between 1 day and 3 |
| Epidural anesthesia | Presence of absence | During cervical rippening and labor, between 6 hours and 3 days |
| Days of postpartum hospitalization | Days | From the delivery to discharge from hospital, between 1 and 7 days |
| Fever during childbirth | Presence of absence | At the moment of the delivery, between 1 day and 3 |
| Perineal injuries | Presence of absence | At the moment of the delivery, between 1 day and 3 |
| Postpartum haemorrage | Presence of absence | At the moment of the delivery, between 1 day and 3 |
| Anemia | Presence of absence | At the moment of the delivery, between 1 day and 3 |
| Uterine rupture | Presence of absence | At the moment of the delivery, between 1 day and 3 |
| Maternal ICU admission | Presence of absence | At the moment of the delivery, between 1 day and 3 |
| Sepsis | Presence of absence | At the moment of the delivery, between 1 day and 3 |
| Meconial amniotic fluid | Presence of absence | During cervical rippening and labor, between 6 hours and 3 days |
| Arterial pH | pH value of neonatal umbilical artery | At the moment of the delivery, between 1 day and 3 |
| Venous pH | pH value of neonatal umbilical vein | At the moment of the delivery, between 1 day and 3 |
| APGAR score | Score obtained when evaluating neonatal apearance, heart rate, muscular tone, activity, breath, gestures | At the moment of the delivery, between 1 day and 3 |
| Neonatal Intensive Care Unit (NICU) admission | Days | From the delivery to discharge from hospital, between 1 and 7 days |
| Neonatal antibiotic administracion | Presence of absence | From the delivery to discharge from hospital, between 1 and 7 days |
| Neonatal death | Presence of absence | From the delivery to discharge from hospital, between 1 and 7 days |
| Hypoxic-ischemic encephalopathy | Presence of absence | From the delivery to discharge from hospital, between 1 and 7 days |
| Neonatal seizures | Presence of absence | From the delivery to discharge from hospital, between 1 and 7 days |
| Neonatal intubation or chest compressions | Presence of absence | From the delivery to discharge from hospital, between 1 and 7 days |
| Persistent pulmonary hypertension of the newborn | Presence of absence | From the delivery to discharge from hospital, between 1 and 7 days |
| Pain/Discomfort | Measure with analogue scale from 1 to 10 | During insertion of the cervical balloon, between 1 and 3 minutes |
| Pain/Discomfort | Measure with analogue scale from 1 to 10 | During cervical rippening, about 6 hours |
| Labor Agentry Scale | Score obtained adding different items on the Scale | Up to two months |
| Edinburg questionnaire for postpartum depression | Score obtained adding different items on the Scale | Up to two months |
| Impact of Event Scale-Revised | Score obtained adding different items on the Scale | Up to two months |
| Breastfeeding | Presence of abscence | Up to two months |
| SF-12 questionnaire | Score obtained adding different items on the Scale | Up to two months |
| Diagnosis of depression | Presence or Absence | Up to two months |
| Medical costs | Measured in euros | One year |
| At time of recruitment and end of delivery, about 1 or 2 days |
| Language spoken at home | Cathegorical variable, it will be studied the different ethnicities of the patients | At time of recruitment and end of delivery, about 1 or 2 days |
| Socioeconomic data | Number of people in the home, type of dwelling, socio-professional category, level of education | At time of recruitment and end of delivery, about 1 or 2 days |
| Height and weight | Measured in centimeters and kilograms, combined in Body Mass Index | At time of recruitment and end of delivery, about 1 or 2 days |
| Anna Mundó Fornell | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Study Chair |
| Ignacio Montoro Pacha | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Study Chair |
| Bruna Miarons Ferré | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Study Chair |
| Mitsury Flores | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Study Chair |