Induction to Labour With Double Cervical Ballon at Home Versus at Hospital

Study Overview
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Brief Summary
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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: Can the induction to labour at home with cervical rippening ballon increase the vaginal delivery rate? Will the induction to labour at home increase maternal satisfaction Will the induction to labour at home improve medical circuits and coulb it be cost effective? Participants who meet inclusion criteria will undergo randomization so as to be asignated an induction to labour at home or in the hospital. Researchers will compare both labour induction groups to see if the induction to labour at home has better outcomes as described previously.

Detailed Description
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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.

Official Title
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Induction to Labour With Double Cervical Ballon at Home Versus at Hospital to Improve the Vaginal Delivery Rate, Maternal Satisfaction and Reduce Costs: Multicentric Randomized Clinical Trial

Conditions
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Induced; Birth, Cervical Dilatation, Live Birth

Intervention / Treatment
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* Device: Cervical rippening at home
* Device: Cervical rippening in the hospital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with ages >18 y.o Being able to read and understand the informed consent Accept to join the study when signing the informed consent Singleton Cephalic presentation Weeks of gestation between equal or more than 37 and less than 42 Low risk indication of labor induction: Cronologically prolonged gestation Intermediate risk indication of labor induction: Macrosoma, Elevated maternal age, Intrahepatic Gestacional Colestasis, Gestational Diabetes Mellitus treated with diet, Gestational Diabetes Mellitus with insulin therapy and correct metabollic controls, Small for gestacional age fetus, Stable chronic hypertension, anterior caesarean section Exclusion Criteria: Premature rupture of membranes (PROM) Breech presentation Unstable presentation Polihydramnios Severe congenital fetal afection Fetal growth restriction Suspected fetal well-being loss on CTG Bishop score equal or higher than seven before insertion of the CRB High cephalic presentation Home further than 30min from Hospital Preeclampsia Diabetes Mellitus type 1 Maternal Hypertension Other maternal pathology with severe compromise Vaginal delivery Exclusion: Oclusive and non-occlusive placenta previa (marginal or low insertion) Vasa previa Transverse / Oblique situation Cord prolapse History of previous caesarean section with uterine incission in inverted T History of uterine rupture Two or more previous Caesarean section Active genital herpetical infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: At home patients group<br>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. | Device: Cervical rippening at home<br>* 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<br>|
| Active Comparator: Hospitalized patients group<br>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. | Device: Cervical rippening in the hospital<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type of delivery | Vaginal birth, Cesarean section | End of the delivery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |