Efficacy of Bicarbonate on the Risk of Assisted Delivery in Nulliparous Women With Prolonged Labour

N/ANot Yet RecruitingNCT07321379

Copenhagen University Hospital, Hvidovre1,520 enrolled

Overview

The goal of this clinical trial is to learn if oral bicarbonate can treat prolonged labour in nulliparous women with prolonged labour. The main question it aims to answer is: Do oral bicarbonate and restrictive oxytocin use reduce assisted delivery rate (emergency cesarean and vacuum/forceps delivery) in nulliparous women with prolonged labour. Researchers will compare bicarbonate and placebo (a look-alike substance that contains no drug) to see if bicarbonate works to treat prolonged labour. Participants will: * drink bicarbonate or placebo * have cervical dilatation reassessed after 2 hours. If still slow progression, they will follow standard protocol for oxytocin augmentation * will receive a questionnaire 1 month post partum to assess birth experience 1/3 of participants will have amniotic fluid lactate measured at inclusion and after 2 hours

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,520

Conditions

Prolonged Labor Labor Dystocia

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥18 years. * Danish or English speaking. * Cephalic presentation. * Gestational age ≥34+0 - \<42+0 (days +weeks) at onset of labour. * Normal foetal heart rate pattern in the 20 minutes prior to inclusion. * Spontaneous onset of labour or non-medical induced labour (balloon catheter and/or artificial rupture of membranes). * Active first stage of labour confirmed, according to Danish national guidelines: Cervical dilatation at ≥4 - \<10 cm with regular painful contractions. * Prolonged labour diagnosed, according to Danish national guidelines: Cervical dilatation progresses at less than 2 cm over a 4-hour period. Exclusion Criteria: * Clinical suspicion of infection (2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics initiated) * Significant medical comorbidity in the form of renal or heart condition, assessed case-by-case basis. * Serious obstetric complication * Known allergy or intolerance to sodium bicarbonate. * Ingestion of sodium bicarbonate in active labour prior to inclusion. * Current treatment with following medicines: Gabpabpentin, Tetracycline, Ketoconazole (NB! These medications are already generally advised contradicted against induring pregnancy)

Locations (3)

Aarhus University Hospital

Aarhus, Denmark

Copenhagen University Hospital, Hvidovre

Copenhagen, Denmark

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

Difference in incidence of assisted delivery

Defined as a composite of emergency caesarean section and instrumental vaginal delivery

Time frame: At birth

Secondary Outcomes

Difference in adverse neonatal outcome

Composite of perinatal adverse outcomes within the first 7 days of life, including perinatal mortality and neonatal morbidity. Neonatal morbidity is defined as arterial umbilical cord pH \<7.10, resuscitation (bag and mask or intubation), hypoxic ischemic encephalopathy II-III, intracranial haemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit.

Time frame: From birth until 7 days postpartum

Difference in total oxytocin dose

Administered intrapartum for augmentation.

Time frame: Intrapartum

Difference in duration of active labour

From diagnosis of active labour until childbirth

Time frame: Intrapartum

Difference in birth experience

Patient reported using Childbirth Experience Questionnaire (CEQ) which uses a 4-point Likert scale and higher scores indicate a more positive experience.

Time frame: One month postpartum

Difference in amniotic fluid lactate (AFL) concentration

Collected in the labourroom and analysed externally. Attending clinicians will not know the AFL.

Time frame: Measured at inclusion and two hours later.

Difference in intra- or postpartum infection

2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics.

Time frame: Intrapartum and until 7 days postpartum

Difference in epidural analgesia

As documented in the case records

Time frame: Intrapartum

Difference in number of women getting antibiotics during labour

As documented in the case records.

Time frame: Intrapartum

Difference in postpartum blood loss

Visual assessment estimated by the attending midwife or calculated using a weight if suspected postpartum haemorrhage.

Time frame: From birth until 24 hours postpartum

Difference in women receiving tocolytics used during labour

Recorded in the case records

Time frame: Intrapartum

Difference in number of 3rd or 4th-degree perineal tears

Assess by the midwife/doctor suturing the tear.

Time frame: Within 2 hours after birth

Central Contacts

Nanna Maaløe, PI, PhD

CONTACT

+4541271984 nannam@sund.ku.dk

Nina Olsén Nathan, Co-PI, PhD

CONTACT

+4553670600 nina.olsen.nathan@regionh.dk