Induction of Labor
Conditions
Keywords
Induction of labor, Low-risk pregnancies, Double-balloon catheter, Prostaglandin E2
Brief summary
To compare the effectiveness and safety of double balloon catheter and vaginal insert Prostaglandin E2 in cervical ripening prior to Induction of Labor in low-risk women from 39+0 to 40+6 weeks of gestation.
Detailed description
Induction of labor (IOL) is a technique to establish vaginal delivery when the risks for continuing the pregnancy for mother or baby are higher than the risks of delivery. In case the cervix is unripe, cervical ripening before the onset of labor is needed. The two main mechanisms of cervical ripening can be categorized as mechanical or pharmacological. A Cochrane systematic review and other recent meta-analysis have shown that cervical ripening with a balloon is probably as effective as induction of labor with vaginal Prostaglandin E2. However, this conclusion is based on low to moderate quality evidence. Only a limited number of randomized clinical trials (RCTs) have been conducted. Many of those suffering from small sample sizes and different study subjects, i.e. high-risk subjects only, and mixed population. In current practice, induction of labor is not only used in high-risk patients with clear indications for pregnancy termination. The ARRIVE trial has shown a significant benefit of labor induction over expectant management among the low-risk population. Based on this evidence, the American College of Obstetricians and Gynecologists (ACOG) has suggested: It's time to induce of labor at 39th week of gestation. Since then, there is a trend in favoring elective induction before the due date over expectant management. Besides, more and more pregnant women want to shorten the duration of pregnancy or to time the birth of the baby due to the convenience of the mother and/or healthcare workers. This makes the optimal method of Induction of Labor in terms of effectiveness and safety for both mothers and their babies even more important. In this study, the investigators will compare the effectiveness and safety of double-balloon catheter and Prostaglandin E2 for elective labor induction in low-risk pregnancies.
Interventions
DEVICEDouble-balloon catheter (UTAH CVX-RIPE) for cervical ripening
Sweeping the membranes by UTAH CVX-RIPE® (Utah Medical Products, Inc, 7043 South 300 West, Midvale, Utah 84047 USA). The catheter will be inserted manually until the proximal balloon is in the cervical canal, the distal balloon should be intrauterine and in the extra-amniotic space. The intrauterine balloon is inflated with 40mL saline and retracted so that it rests against the internal oz. The proximal balloon should now be outside the external oz and is inflated with 20mL saline. If the balloons are correctly situated on both ends of the cervix, they can be inflated with up to 80mL saline each. Cardiotocograph will be performed 30min, 2 hours after insertion and every 6 hours. The balloon is placed for a maximum of 24 hours. If it is expelled in the first 12 hours and the patient has no contractions or still shows an unfavorable cervix, another balloon is placed for a maximum of another 24 hours. The patients will be examined in case of extremely painful or membranes ruptured.
DRUGDinoprostone 10mg (Propess)
Propess® 10mg Vaginal delivery system (Ferring Controlled Therapeutics Ltd., 1 Redwood Place, Peel Park Campus, East Kilbride, Glasgow, G74 5PB, UK) is a vaginal insert containing 10mg of dinoprostone in a timed-release formulation (the medication is released at 0.3 mg/hour). A Propess vaginal system is inserted by a research doctors. As in the catheter procedure, Fetal Heart Rate is monitored 30min before and 2 hours after placement. Cardiotocograph and vaginal examination will be performed every 6 hours. The vaginal system is placed for a maximum of 24 hours. If it is expelled in the first 12 hours and the patient has no contractions or still shows an unfavorable cervix, another vaginal system is placed for a maximum of another 24 hours. The patients will be examined in case of extreme pain or membranes ruptured.
Sponsors
Mỹ Đức Hospital
Hanoi Obstetrics and Gynecology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Low-risk pregnant women eligible for study will be asked to sign the informed consent form. Then, they will be randomly assigned in a 1:1 ratio to receive either double balloon insertion or vaginal prostaglandin E2
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Maternal age ≥ 18 2. Singleton pregnancy. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks gestational age. 3. Gestational age at randomization from at 39+0 to 40+6 weeks of gestation. 4. Cephalic presentation 5. Intact membrane 6. Unfavourable cervix (Bishop\<6) 7. Informed consent
Exclusion criteria
1. Maternal medical illness associated with increased risk of adverse pregnancy outcome (any diabetes mellitus, any hypertensive disorders, cardiac diseases, renal insufficiency, systemic lupus erythematosus, mental disorders, HIV positive, use of heparin or low-molecular weight heparin during the current pregnancy etc.) 2. Abnormal placenta: Active vaginal bleeding greater than bloody show or placenta previa, accreta or vasa previa 3. Abnormal amniotic fluid volume: * Oligohydramnios (MVP \< 2cm) * Polyhydramnios (MVP \> 10cm) 4. Abnormal fetus * Fetal demise or known major fetal anomalies * Fetal growth restriction (FGR) (EFW \< 3% or \< 10% and abnormal Doppler) * Non-reassuring fetal status (no fetal movements, abnormal fetal heart rate at auscultation) 5. Previous C-section 6. Planned for C-section or contra-indication to labour 7. Cerclage or use of pessary in current pregnancy 8. Refusal of blood product. 9. Participation in another interventional study that influences management of labour at delivery or perinatal morbidity or mortality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants delivered vaginally | From randomization until delivery, assessed up to 3 days after randomization | Number of participants delivered vaginally |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants using more than one induction agent required | From induction until delivery, assessed up to 3 days after induction | Number of participants using more than one induction agent required |
| Number of participants having oxytocin augmentation | From induction until delivery, assessed up to 3 days after induction | Number of participants having oxytocin augmentation |
| Number of participants with uterine tachysystole | From induction until delivery, assessed up to 3 days after induction | Defined as more than 5 contractions in 10 minutes over a minimal period of two times 10 minutes with Fetal Heart Rate changes and/or a contraction lasting more than 3 minutes with Fetal Heart Rate changes. |
| Time from induction of labor to delivery | From induction until delivery, assessed up to 3 days after induction | Duration from induction to delivery (hours) |
| Number of participants delivered vaginally within 24 hours | Within 24 hours from labor induction | Number of participants delivered vaginally within 24 hours |
| Number of participants with post-partum haemorrhage | Within 24 hours from delivery | Defined as blood loss \>500 ml at vaginal birth or \>1000 ml at caesarean birth within 24 hours after birth |
| Number of participants having uterine atony | From delivery until maternal hospital discharge, assessed up to 28 days after delivery | Use of two or more uterotonics other than oxytocin; other surgical interventions such as uterine compression by hands and/or sutures, uterine artery ligation, embolization, hypogastric ligation, or balloon tamponade). |
| Number of participants having maternal post-partum blood transfusion | From delivery until maternal hospital discharge, assessed up to 28 days after delivery | Number of participants having maternal post-partum blood transfusion |
| Number of participants with hypertension complications | From randomization until maternal hospital discharge, assessed up to 28 days after randomization | Number of participants with hypertension complications |
| Number of participants with uterine dehiscence or rupture | From delivery until maternal hospital discharge, assessed up to 28 days after delivery | Uterine dehiscence (defined as clinically asymptomatic disruption of the uterus that is discovered incidentally at surgery) or rupture (defined as clinically significant rupture involving the full thickness of the uterine wall and requiring surgical repair) |
| Number of participants with maternal infection | From induction until maternal hospital discharge, assessed up to 28 days after induction | * Fever (defined as a temperature ≥37.5 degrees Celsius) * Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation) * Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture) |
| Number of participants with hysterectomy | From delivery until maternal hospital discharge, assessed up to 28 days after delivery | Hysterectomy for any postpartum complications |
| Number of participants with damage to internal organs | From delivery until maternal hospital discharge, assessed up to 28 days after delivery | Including intestines, bladder or ureters |
| Number of participants with other post-partum complications | From randomization until maternal hospital discharge, assessed up to 28 days after randomization | Includes: venous embolism, pulmonary embolism, stroke, cardiac arrest |
| Number of participants admitted to intensive care unit | From randomization until maternal hospital discharge, assessed up to 28 days after randomization | Number of participants admitted to intensive care unit |
| Number of maternal death among participants | From randomization until maternal hospital discharge, assessed up to 28 days after randomization | Maternal death from randomization through hospital discharge |
| Number of participants referred to other hospital due to severe morbidities | From randomization until maternal hospital referral, assessed up to 28 days after randomization | Including: pulmonary embolus, stroke, cardiorespiratory arrest, etc. |
| Maternal length of stay | From admission until maternal hospital discharge, assessed up to 28 days after admission | Duration of stay in hospital (days) |
| Number of participants with Side - effect of induction's method | From induction until delivery, assessed up to 3 days after induction | Including any of: nausea, vomiting, diarrhea, pain... |
| Apgar scores at 1 and 5 minute | Assessed at 1 and 5 minute after birth | Apgar scores at 1 and 5 minute |
| Number of Infants with Apgar Score ≤7 at 1 and 5 minutes | Assessed at 1 and 5 minute after birth | Infants with Apgar Score ≤7 at 1 and 5 minutes |
| Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit | From delivery until admission to Neonatal Intensive Care Unit or Intermediate care unit, assessed up to 7 days after delivery | Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit |
| Reason for Neonatal Intensive Care Unit admission | From delivery until Neonatal Intensive Care Unit admission, assessed up to 28 days after delivery | Reason for Neonatal Intensive Care Unit admission such as: respiratory distress, hypoglycemia, seizures, etc. |
| Length of stay at the Neonatal Intensive Care Unit or Intermediate care unit | From admission to Neonatal Intensive Care Unit/ Intermediate care unit until neonatal discharge or hospital referral, assessed up to 28 days after Neonatal Intensive Care Unit admission | Duration from admission to Neonatal Intensive Care Unit or Intermediate care unit to Neonatal Intensive Care Unit/ Intermediate care unit discharge or hospital referral |
| Number of neonates with birth trauma | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Include: bone fractures, traumatic pneumothorax, facial nerve palsy, other neurologic injury (Brachial plexus palsy...), etc. |
| Number of neonates with hypoglycemia | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Number of neonates with hypoglycemia |
| Number of neonates with jaundice and hyperbilirubinemia | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Number of neonates with jaundice and hyperbilirubinemia |
| Number of neonates with Hypoxic ischemic encephalopathy or need for therapeutic hypothermia | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Number of neonates with Hypoxic ischemic encephalopathy or need for therapeutic hypothermia |
| Number of neonates with meconium aspiration syndrome | From delivery until neonatal hospital discharge, assessed up to 07 days after delivery | Criteria include: * Meconium-stained amniotic fluid * Respiratory distress at birth or shortly after birth * Characteristic radiographic features: The initial chest film may show streaky, linear densities -\> the lungs typically appear hyper-inflated with flattening of the diaphragms. |
| Number of neonates in need for respiratory supports | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Incubation, Continuous Positive Airway Pressure, or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within the first 72 hours |
| Number of neonates with neonatal infection | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Presence of a clinically ill infant in whom systemic infection is suspected with a positive blood, cerebrospinal fluid (CSF), or catheterized/supra-pubic urine culture; or, in the absence of positive cultures, clinical evidence of cardiovascular collapse or an X-ray confirming infection |
| Number of neonates with neonatal seizures | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Number of neonates with neonatal seizures |
| Number of neonates with intracranial hemorrhage | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Intra-ventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma Subgaleal hematoma, subdural hematoma, or subarachnoid hematoma |
| Number of neonates need blood transfusion | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Number of neonates need blood transfusion |
| Number of neonatal deaths | From delivery until neonatal hospital discharge, assessed up to 28 days after delivery | Includes: Intrapartum/neonatal/perinatal deaths |
| Number of neonates referred to other hospital for severe morbidities | From delivery until neonatal hospital referral, assessed up to 28 days after delivery | Number of neonates referred to other hospital for severe morbidities |
| Psychometric aspects | At admission (version A) and before maternal hospital discharge (version B), assessed up to 28 days after admission | Feelings and thoughts pregnant women at antepartum and postpartum will be evaluated by Wijma Delivery Expectancy/Experience Questionnaires' (W-DEQ) version A and version B, respectively, expected to be filled out in approximately 30 minutes This is a questionnaire which measures a construct of fear related to childbirth during pregnancy and after delivery by asking the woman about her expectancies before delivery(version A) - performed at admission, and experiences after delivery (version B) - performed before maternal hospital discharge respectively. When filling in the W-DEQ, the woman is instructed to rate her personal feelings and cognitions on a six-point scale. The minimum score is 0 and the maximum score is 126. The higher the score, the greater the fear of childbirth manifested. |
Countries
Vietnam
Contacts
Primary ContactHa Nguyen Thi Thu, PhD. MD
Backup ContactToan Nguyen Khac, MSc. MD
Outcome results
None listed