Neonatal Respiratory DistressARTCONNCT03899597
The Role of ARTificial Uterine CONtractions in Perinatal Respiratory Morbidity of Term Infants Delivered by Elective Caesarean Section
A study testing Oxytocin and Normal saline in people with Neonatal Respiratory Distress, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- Oxytocin and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 30 Jan 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute for the Care of Mother and Child
Prague, 14700
Ivan Berka, MD, 0042296511807, ivan.berka@upmd.eu
About this study
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
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.
Read the 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.
- Conditions
- Neonatal Respiratory Distress
- Being tested
- Oxytocin, Normal saline
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
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.
Normal salineOther
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| artificial contractions (ARTCON) group | Experimental | 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. Receives: Drug: Oxytocin |
| standard approach (SA) group | Placebo comparator | 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. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of neonatal respiratory morbidity
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.
Measured: First 24 hours after delivery
Secondary outcomes (11)
Oxytocin challenge test effectivity
Contractions being induced (felt or CTG recorded) before elective caesarean section
Measured: Before elective caesarean section
Oxytocin challenge test safety and feasibility
CTG trace suggestive of hypoxia during oxytocin exposure. Subjectively unbearable pain and discomfort during oxytocin exposure.
Measured: Before elective caesarean section
Maternal blood loss
Defined as the difference in hemoglobin levels before and after surgery
Measured: During caesarean section
Total duration of surgery
Minutes
Measured: Time of caesarean section
Lamellar body count in amniotic fluid
Particles per microlitre
Measured: During caesarean section
Incidence of transitory tachypnoea of the newborn
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.
Measured: First 24 hours after delivery
Incidence of respiratory distress syndrome
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.
Measured: First 24 hours after delivery
Incidence of perinatal hypoxia
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
Measured: First 24 hours after delivery
Incidence of early onset sepsis
Clinical or proven (positive blood culture)
Measured: First 48 hours after delivery
Incidence of significantly increased neonatal pulmonary vascular resistance
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).
Measured: First 72 hours after delivery
Incidence of persistent pulmonary hypertension of the newborn
Defined by marked pulmonary hypertension that causes hypoxemia secondary to right-to-left shunting of blood at the foramen ovale and ductus arteriosus.
Measured: First 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start30 Jan 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for the Care of Mother and Child, Prague, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivan Berka, Institute for the Care of Mother and Child, Prague, Czech Republic
- Investigators
- Ivan Berka, MD, Principal investigator, Institute for the Care of Mother and Child, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899597
- Sponsor's protocol ID
- ARTCON Study Protocol
- Acronym
- ARTCON
- Status last verified
- Nov 2022
- First submitted
- 31 Mar 2019
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03899597
- Acronym / sponsor ID
- ARTCON / ARTCON Study Protocol
- Conditions
- Neonatal Respiratory Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute for the Care of Mother and Child, Prague, Czech RepublicUniversity, hospital or other
- Study start
- 30 Jan 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artificial contractions (ARTCON) group | Experimental | Drug: OxytocinAll 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. |
| standard approach (SA) group | Placebo comparator | Other: Normal salineAll 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Term premature rupture of membranes (TPROM)
- Spontaneous onset of uterine contractions
- Known serious congenital malformations
- Placenta praevia/vasa praevia
- Abnormal placental attachment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinThe 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. | Drug | artificial contractions (ARTCON) group |
| Normal salineAlso: PlaceboThe 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 | standard approach (SA) group |
Primary outcome
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.
11 secondary outcomes
Oxytocin challenge test effectivity
Time frame: Before elective caesarean section
Oxytocin challenge test safety and feasibility
Time frame: Before elective caesarean section
Maternal blood loss
Time frame: During caesarean section
Total duration of surgery
Time frame: Time of caesarean section
Lamellar body count in amniotic fluid
Time frame: During caesarean section
Incidence of transitory tachypnoea of the newborn
Time frame: First 24 hours after delivery
Incidence of respiratory distress syndrome
Time frame: First 24 hours after delivery
Incidence of perinatal hypoxia
Time frame: First 24 hours after delivery
Incidence of early onset sepsis
Time frame: First 48 hours after delivery
Incidence of significantly increased neonatal pulmonary vascular resistance
Time frame: First 72 hours after delivery
Incidence of persistent pulmonary hypertension of the newborn
Time frame: First 24 hours after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Berka, MD principal investigator
Institute for the Care of Mother and Child, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxytocin and Normal saline in people with Neonatal Respiratory Distress, run by Institute for the Care of Mother and Child, Prague, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ivan Berka, MD (0042296511807, ivan.berka@upmd.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of neonatal respiratory morbidity (time frame: First 24 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.