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The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section (ARTCON)

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ClinicalTrials.gov Identifier: NCT03899597
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ivan Berka, Institute for the Care of Mother and Child, Prague, Czech Republic

Brief Summary:
In this study, the investigators aim to investigate if artificial uterine contractions prior to elective caesarean section delivery may have an impact on the respiratory morbidity of term neonates.

Condition or disease Intervention/treatment Phase
Neonatal Respiratory Distress Drug: Oxytocin Other: Normal saline Not Applicable

Detailed Description:

Accumulating evidence suggests that the respiratory morbidity of infants is lower if delivered by caesarean section after the spontaneous onset of uterine contractions, or after oxytocin exposure. Moreover, benefits for the mother due to stretching of the lower uterine segment and possible lower blood loss are plausible.

In obstetrics, there is a well described and standardized way to induce artificial uterine contractions in order to predict fetal wellbeing and tolerance of labor, without inducing the labor itself. This is the oxytocin challenge test (OCT). Although the OCT has not been performed previously in the context of planned elective caesarean section deliveries, it is generally considered a safe procedure if appropriate monitoring is granted. Hence evaluation of the role of artificial uterine contractions in perinatal respiratory morbidity of term infants delivered by elective caesarean section is possible and of interest.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized and Placebo Controlled Trial Comparing the Role of ARTificial Uterine CONtractions and no Intervention in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section - ARTCON Study
Estimated Study Start Date : May 31, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : September 30, 2020


Arm Intervention/treatment
Experimental: artificial contractions (ARTCON) group
All participating patients in the intervention (ARTCON) group will undergo oxytocin exposure in the form of a continuous intravenous infusion according to dosage guidelines of The Czech Society of Obstetrics and Gynaecology. The exposure will take two hours to complete and should be finished at least one hour before elective caesarean section is performed in order for the assumed effects of physiological stress associated with labor to occur.
Drug: Oxytocin
The intervention group (ARTCON) will receive the standard assignment for the elective caesarean section, but at least one hour before surgery oxytocin exposure will be performed with cardiotocographic (CTG) monitoring and obstetrical supervision.

Placebo Comparator: standard approach (SA) group
All participating patients in the control (SA) group will undergo placebo exposure in the form of a continuous intravenous infusion. The exposure will take two hours to complete and should be finished at least one hour before elective caesarean section is performed.
Other: Normal saline
The control group (SA) will receive the standard assignment for the elective caesarean section, but at least one hour before surgery placebo exposure will be performed with cardiotocographic (CTG) monitoring and obstetrical supervision.
Other Name: Placebo




Primary Outcome Measures :
  1. Incidence of neonatal respiratory morbidity [ Time Frame: First 24 hours after delivery ]
    Neonatal respiratory morbidity during the first 24 hours after delivery is defined as presence of transitory tachypnoea of the newborn, or respiratory distress syndrome, and/or persistent pulmonary hypertension of the newborn.


Secondary Outcome Measures :
  1. Oxytocin challenge test effectivity [ Time Frame: Before elective caesarean section ]
    Contractions being induced (felt or CTG recorded) before elective caesarean section

  2. Oxytocin challenge test safety and feasibility [ Time Frame: Before elective caesarean section ]
    CTG trace suggestive of hypoxia during oxytocin exposure. Subjectively unbearable pain and discomfort during oxytocin exposure.

  3. Maternal blood loss [ Time Frame: During caesarean section ]
    Defined as the difference in hemoglobin levels before and after surgery

  4. Total duration of surgery [ Time Frame: Time of caesarean section ]
    Minutes

  5. Lamellar body count in amniotic fluid [ Time Frame: During caesarean section ]
    Particles per microlitre

  6. Incidence of transitory tachypnoea of the newborn [ Time Frame: First 24 hours after delivery ]
    Breathing rate above 60 per minute at least for 3 hours (3 consecutive measurements) and /or dyspnoea for at least two hours in the follow-up period (consecutive) and /or the need for oxygen therapy during the first 24 hours after birth.

  7. Incidence of respiratory distress syndrome [ Time Frame: First 24 hours after delivery ]
    Defined by need for ventilatory support in the first 24 hours after birth (nasal continuous positive airway pressure, mechanical ventilation) and X-ray examination results consistent with RDS diagnosis.

  8. Incidence of perinatal hypoxia [ Time Frame: First 24 hours after delivery ]
    Presence of diagnostic criteria of hypoxic-ischaemic encephalopathy: 5-min Apgar score of less than 5, need for delivery room intubation or CPR, umbilical cord arterial pH less than 7.00 and abnormal neurological signs such as hypotonic muscles or lack of sucking reflex

  9. Incidence of early onset sepsis [ Time Frame: First 48 hours after delivery ]
    Clinical or proven (positive blood culture)

  10. Incidence of significantly increased neonatal pulmonary vascular resistance [ Time Frame: First 72 hours after delivery ]
    Pulmonary vascular resistance measurements consist of measuring the right ventricular systolic pressure (RVSP), pulmonary artery pressure (PAP) and persistent ductus arteriosus (PDA) shunting (if present).

  11. Incidence of persistent pulmonary hypertension of the newborn [ Time Frame: First 24 hours after delivery ]
    Defined by marked pulmonary hypertension that causes hypoxemia secondary to right-to-left shunting of blood at the foramen ovale and ductus arteriosus.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term/near-term pregnancy (36+0 - 41+6 weeks of gestation)
  • Planned delivery by elective caesarean section
  • Absence of any exclusion criteria
  • Informed consent obtained

Exclusion Criteria:

  • Term premature rupture of membranes (TPROM)
  • Spontaneous onset of uterine contractions
  • Known serious congenital malformations
  • Placenta praevia/vasa praevia
  • Abnormal placental attachment
  • Intrauterine growth restriction (birth weight below 3rd centile for given gestational age and gender)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03899597


Contacts
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Contact: Ivan Berka, MD 0042296511807 ivan.berka@upmd.eu
Contact: Zbynek Stranak, MD 0042296511806 zbynek.stranak@upmd.eu

Locations
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Czechia
Institute for the Care of Mother and Child Not yet recruiting
Prague, Czechia, 14700
Contact: Ivan Berka, MD    0042296511807    ivan.berka@upmd.eu   
Sponsors and Collaborators
Institute for the Care of Mother and Child, Prague, Czech Republic
Investigators
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Principal Investigator: Ivan Berka, MD Institute for the Care of Mother and Child, Prague, Czech Republic

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Responsible Party: Ivan Berka, Head of Neonatal Intensive Care Unit, Institute for the Care of Mother and Child, Prague, Czech Republic
ClinicalTrials.gov Identifier: NCT03899597     History of Changes
Other Study ID Numbers: ARTCON Study Protocol
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs