NCT03899597

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
4.8 years until next milestone

Study Start

First participant enrolled

January 30, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

March 31, 2019

Last Update Submit

November 1, 2022

Conditions

Neonatal Respiratory Distress

Outcome Measures

Primary Outcomes (1)

  • 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.

    First 24 hours after delivery

Secondary Outcomes (11)

  • Oxytocin challenge test effectivity

    Before elective caesarean section

  • Oxytocin challenge test safety and feasibility

    Before elective caesarean section

  • Maternal blood loss

    During caesarean section

  • Total duration of surgery

    Time of caesarean section

  • Lamellar body count in amniotic fluid

    During caesarean section

  • +6 more secondary outcomes

Study Arms (2)

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.

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.

Other: Normal saline

Interventions

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.

artificial contractions (ARTCON) group
Normal salineOTHER

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.

Also known as: Placebo
standard approach (SA) group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Term/near-term pregnancy (36+0 - 41+6 weeks of gestation)
  • Planned delivery by elective caesarean section

You may not qualify if:

  • Informed consent obtained
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for the Care of Mother and Child

Prague, 14700, Czechia

Location

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

OxytocinSaline Solution

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Ivan Berka, MD

    Institute for the Care of Mother and Child, Prague, Czech Republic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivan Berka, MD

CONTACT

0042296511807ivan.berka@upmd.eu

Zbynek Stranak, MD

CONTACT

0042296511806zbynek.stranak@upmd.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neonatal Intensive Care Unit

Study Record Dates

First Submitted

March 31, 2019

First Posted

April 2, 2019

Study Start

January 30, 2024

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

November 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)