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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
540
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.
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.
Hanoi Obstetrics and Gynecology Hospital
Hanoi, Hanoi, Vietnam
RECRUITINGNumber of participants delivered vaginally
Number of participants delivered vaginally
Time frame: From randomization until delivery, assessed up to 3 days after randomization
Number of participants with Side - effect of induction's method
Including any of: nausea, vomiting, diarrhea, pain...
Time frame: From induction until delivery, assessed up to 3 days after induction
Number of participants using more than one induction agent required
Number of participants using more than one induction agent required
Time frame: From induction until delivery, assessed up to 3 days after induction
Number of participants having oxytocin augmentation
Number of participants having oxytocin augmentation
Time frame: From induction until delivery, assessed up to 3 days after induction
Number of participants with uterine tachysystole
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 frame: From induction until delivery, assessed up to 3 days after induction
Time from induction of labor to delivery
Duration from induction to delivery (hours)
Time frame: From induction until delivery, assessed up to 3 days after induction
Number of participants delivered vaginally within 24 hours
Number of participants delivered vaginally within 24 hours
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Time frame: Within 24 hours from labor induction
Number of participants with post-partum haemorrhage
Defined as blood loss \>500 ml at vaginal birth or \>1000 ml at caesarean birth within 24 hours after birth
Time frame: Within 24 hours from delivery
Number of participants having uterine atony
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).
Time frame: 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 having maternal post-partum blood transfusion
Time frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants with hypertension complications
Number of participants with hypertension complications
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants with uterine dehiscence or rupture
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)
Time frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants with maternal infection
* 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)
Time frame: From induction until maternal hospital discharge, assessed up to 28 days after induction
Number of participants with hysterectomy
Hysterectomy for any postpartum complications
Time frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants with damage to internal organs
Including intestines, bladder or ureters
Time frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants with other post-partum complications
Includes: venous embolism, pulmonary embolism, stroke, cardiac arrest
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants admitted to intensive care unit
Number of participants admitted to intensive care unit
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of maternal death among participants
Maternal death from randomization through hospital discharge
Time frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants referred to other hospital due to severe morbidities
Including: pulmonary embolus, stroke, cardiorespiratory arrest, etc.
Time frame: From randomization until maternal hospital referral, assessed up to 28 days after randomization
Maternal length of stay
Duration of stay in hospital (days)
Time frame: From admission until maternal hospital discharge, assessed up to 28 days after admission
Psychometric aspects
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.
Time frame: At admission (version A) and before maternal hospital discharge (version B), assessed up to 28 days after admission
Apgar scores at 1 and 5 minute
Apgar scores at 1 and 5 minute
Time frame: Assessed at 1 and 5 minute after birth
Number of Infants with Apgar Score ≤7 at 1 and 5 minutes
Infants with Apgar Score ≤7 at 1 and 5 minutes
Time frame: Assessed at 1 and 5 minute after birth
Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit
Number of neonates admitted to the Neonatal Intensive Care Unit or Intermediate care unit
Time frame: From delivery until admission to Neonatal Intensive Care Unit or Intermediate care unit, assessed up to 7 days after delivery
Reason for Neonatal Intensive Care Unit admission
Reason for Neonatal Intensive Care Unit admission such as: respiratory distress, hypoglycemia, seizures, etc.
Time frame: From delivery until Neonatal Intensive Care Unit admission, assessed up to 28 days after delivery
Length of stay at the Neonatal Intensive Care Unit or Intermediate care unit
Duration from admission to Neonatal Intensive Care Unit or Intermediate care unit to Neonatal Intensive Care Unit/ Intermediate care unit discharge or hospital referral
Time frame: 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
Number of neonates with birth trauma
Include: bone fractures, traumatic pneumothorax, facial nerve palsy, other neurologic injury (Brachial plexus palsy...), etc.
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with hypoglycemia
Number of neonates with hypoglycemia
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with jaundice and hyperbilirubinemia
Number of neonates with jaundice and hyperbilirubinemia
Time frame: 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 Hypoxic ischemic encephalopathy or need for therapeutic hypothermia
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with meconium aspiration syndrome
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.
Time frame: From delivery until neonatal hospital discharge, assessed up to 07 days after delivery
Number of neonates in need for respiratory supports
Incubation, Continuous Positive Airway Pressure, or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation within the first 72 hours
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with neonatal infection
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
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with neonatal seizures
Number of neonates with neonatal seizures
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with intracranial hemorrhage
Intra-ventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma Subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates need blood transfusion
Number of neonates need blood transfusion
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonatal deaths
Includes: Intrapartum/neonatal/perinatal deaths
Time frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates referred to other hospital for severe morbidities
Number of neonates referred to other hospital for severe morbidities
Time frame: From delivery until neonatal hospital referral, assessed up to 28 days after delivery