Labor Dystocia, Prolonged Labor
Conditions
Keywords
Labor, Bicarbonate, Caesarean section, Assisted birth, Oxytocin, Labor augmentation, Intrapartum
Brief summary
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
Interventions
DRUGSodium bicarbonate
4,26 gram given once.
DRUGPlacebo
Placebo given once.
Sponsors
University of Copenhagen
Rigshospitalet, Denmark
Aarhus University Hospital
Copenhagen Trial Unit, Center for Clinical Intervention Research
University of Liverpool
University of Amsterdam
Copenhagen University Hospital, Hvidovre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The active substance, sodium bicarbonate, will be diluted in a glass of 200 ml soda water added flavour. Placebo consist of 200 ml soda water added the same flavor. Bicarbonate/placebo will be prepared in another room by a person not involved in the specific labour. The person will give the drink directly to the woman. Amniotic fluid will be collected and analysed externally.
Intervention model description
The Danish ProLabour Trial is a double-blinded, parallel group, randomized-controlled, superiority trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in incidence of assisted delivery | At birth | Defined as a composite of emergency caesarean section and instrumental vaginal delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in total oxytocin dose | Intrapartum | Administered intrapartum for augmentation. |
| Difference in duration of active labour | Intrapartum | From diagnosis of active labour until childbirth |
| Difference in birth experience | One month postpartum | Patient reported using Childbirth Experience Questionnaire (CEQ) which uses a 4-point Likert scale and higher scores indicate a more positive experience. |
| Difference in amniotic fluid lactate (AFL) concentration | Measured at inclusion and two hours later. | Collected in the labourroom and analysed externally. Attending clinicians will not know the AFL. |
| Difference in intra- or postpartum infection | Intrapartum and until 7 days postpartum | 2 confirmed temperatures ≥38.5°C with epidural, ≥38 °C without epidural, or broad-spectrum antibiotics. |
| Difference in adverse neonatal outcome | From birth until 7 days postpartum | 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. |
| Difference in number of women getting antibiotics during labour | Intrapartum | As documented in the case records. |
| Difference in postpartum blood loss | From birth until 24 hours postpartum | Visual assessment estimated by the attending midwife or calculated using a weight if suspected postpartum haemorrhage. |
| Difference in women receiving tocolytics used during labour | Intrapartum | Recorded in the case records |
| Difference in number of 3rd or 4th-degree perineal tears | Within 2 hours after birth | Assess by the midwife/doctor suturing the tear. |
| Difference in epidural analgesia | Intrapartum | As documented in the case records |
Countries
Denmark
Contacts
Primary ContactNanna Maaløe, PI, PhD
Backup ContactNina Olsén Nathan, Co-PI, PhD
Outcome results
None listed