Effect of Increased Oxytocin Doses on the Mode of Delivery in Obese Primiparous Women With Spontaneous or Induced Labour

Short name PROXYMA

NCTNCT04760496Other id2020-002640-23

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 443 participants (actual)
Sponsor: Assistance Publique - Hôpitaux de Paris · Other
Design: Randomized · Quadruple masking
Countries: 1 country
France
Start: 2 Oct 2021
Primary completion: 30 Dec 2024
Completion: 30 Jan 2025
First posted: 18 Feb 2021
Last update posted: 26 Dec 2025
Conditions: Obese · Primiparous Women · Oxytocin

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202120222023202420252026

Ph 4
PROXYMA
NCT04760496
2 Oct 2021 to 30 Jan 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The rate of caesarean section is higher among obese pregnant women, leading to increased morbidity in this already vulnerable population. Oxytocin is the main drug used in obstetrics to optimize progress of labour, but observational studies have suggested that its efficiency may be insufficient in obese women with usual doses. We design a randomised controlled trial to test the effect of an increased oxytocin dose on the rate of caesarean section in obese primiparous women with spontaneous or induced labour.

Interventions

Oxytocin 4 mIU/mLDrug
Oxytocin 2 mIU/mLDrug

Arms2

Experimental
Experimental group
The experimental group will receive oxytocin at 4 mIU/mL
Active comparator
Control group
The control group will receive oxytocin at 2 mIU/mL

Primary outcomes1

Outcomes the sponsor listed as primary.

Rate of caesarean section during labour
Time frame · through study completion, an average of 1 month
Registry description
The decision of caesarean section is made by the responsible obstetrician in charge of the patient, he or she will be blinded of the patient's group (oxytocin dosage) to avoid differential indication for caesarean section. Therefore, the decision to perform (or not) a caesarean section will be only based on foetal/maternal criteria, independently of oxytocin dosage.

Secondary outcomes(12)

Length of labour phases
Time frame · Through study completion, an average of 1 month
Registry description
Length of labour phases is measured in minutes (from 2 cm of dilation until delivery)
Arrest of labour
Time frame · Through study completion, an average of 1 month
Registry description
It will be evaluated if there is two or more hours without cervical dilation (yes/no)
Interruption of oxytocin perfusion and causes
Time frame · through study completion, an average of 1 month
Registry description
Interruption of oxytocin perfusion (yes/no) and causes (foetal heart anomalies / uterine hyperkinesia / uterine hypertonia / other)
Uterine hyper-stimulation
Time frame · Through study completion, an average of 1 month
Registry description
Uterine hyper-stimulation (more than 5 uterine contractions per 10 min)
Mode of vaginal delivery
Time frame · Through study completion, an average of 1 month
Registry description
Spontaneous or operative delivery.If operative vaginal delivery: indication
Reason for the caesarean section
Time frame · through study completion, an average of 1 month
Registry description
foetal heart anomalies / labour arrest / other
Post-partum haemorrhage
Time frame · Through study completion, an average of 1 month
Registry description
Post-partum haemorrhage (yes/no) and its volume (mL). Post-partum haemorrhage is defined as blood lost ≥ 500 mL in the 2 hours after birth.
Maternal blood transfusion
Time frame · Through study completion, an average of 1 month
Registry description
Maternal blood transfusion (yes/no) (for the duration of the hospitalization)
Volume of oxytocin infusion
Time frame · Through study completion, an average of 1 month
Registry description
Volume of oxytocin infusion (mL/H)
Oxytocin side effects
Time frame · Through study completion, an average of 1 month
Registry description
nausea, vomiting, headaches, increased or decreased heart rate, allergic reaction, skin rash
Foetal complications
Time frame · Through study completion, an average of 1 month
Registry description
* Foetal heart rate anomalies requiring second-line monitoring (as pH/lactate blood test at scalp) or emergency delivery (yes / no) * Appearance of meconium (yes / no) * Chorioamnionitis (yes/no): defined as the combination of 2 of the next 3 signs: maternal fever more than 38°5 during labour and/or foetal heart tachycardia and/or biological infection sign
Neonatal complications
Time frame · Through study completion, an average of 1 month
Registry description
* Apgar score at 5 min * Umbilical arterial cord pH * Neonatal resuscitation (yes / no): defined by at least artificial ventilation * Transfer to neonatal care unit (yes / no)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria Inclusion criteria are the following: * Age ≥ 18 years * Nulliparous (no previous childbirth beyond 22 SA) * BMI ≥ 30 kg/m² at the beginning of pregnancy * Singleton pregnancy * Spontaneous or induced onset of labour * Cephalic presentation * Term ≥ 37 weeks of gestation and \< 42 weeks of gestation * Medical Indication and absence of medical contraindication for oxytocin during labour: inadequate and/or ineffective uterine contraction and/or delayed cervical dilation * Written consent * Affiliation to a french social security system Exclusion criteria Exclusion criteria are the following: * Hypersensitivity to the active substance (oxytocin), to any of its excipients or to latex (risk of cross allergy) * Medical contraindication for oxytocin * Coagulation disorders * Foetal growth restriction (inferior to 5th percentile) * Foetal malformation (major) * Foetal heart rate anomalies before use of oxytocin (at the time of inclusion) * History of uterine surgery (scarred uterus of gynaecological origin) * Patient with a disease requiring caesarean section prior to labour (planned caesarean section before labour) * Severe renal failure * Patient deprived of their liberty (under curatorship or guardianship) * Participation in another interventional trial of category 1. Patients included in interventional research with minimal risk and constraints may participate in the study after the investigator's assessment.

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