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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| Rigshospitalet, Denmark | OTHER |
| Aarhus University Hospital | OTHER |
| Copenhagen Trial Unit, Center for Clinical Intervention Research |
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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:
1/3 of participants will have amniotic fluid lactate measured at inclusion and after 2 hours
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium bicarbonate | Experimental | Participants receive oral sodium bicarbonate 4.26 gram once. |
|
| Placebo | Placebo Comparator | Participants receive placebo once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | Drug | 4,26 gram given once. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in incidence of assisted delivery | Defined as a composite of emergency caesarean section and instrumental vaginal delivery | At birth |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nanna Maaløe, PI, PhD | Contact | +4541271984 | nannam@sund.ku.dk | |
| Nina Olsén Nathan, Co-PI, PhD | Contact | +4553670600 | nina.olsen.nathan@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Nanna Maaløe, PhD | University of Copenhagen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital | Aarhus | 8200 | Denmark |
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| ID | Term |
|---|---|
| D004420 | Dystocia |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| OTHER |
| University of Liverpool | OTHER |
| University of Amsterdam | OTHER |
The Danish ProLabour Trial is a double-blinded, parallel group, randomized-controlled, superiority trial.
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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.
| Drug |
Placebo given once. |
|
| From birth until 7 days postpartum |
| Difference in total oxytocin dose | Administered intrapartum for augmentation. | Intrapartum |
| Difference in duration of active labour | From diagnosis of active labour until childbirth | 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. | One month postpartum |
| Difference in amniotic fluid lactate (AFL) concentration | Collected in the labourroom and analysed externally. Attending clinicians will not know the AFL. | 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. | Intrapartum and until 7 days postpartum |
| Difference in epidural analgesia | As documented in the case records | Intrapartum |
| Difference in number of women getting antibiotics during labour | As documented in the case records. | Intrapartum |
| Difference in postpartum blood loss | Visual assessment estimated by the attending midwife or calculated using a weight if suspected postpartum haemorrhage. | From birth until 24 hours postpartum |
| Difference in women receiving tocolytics used during labour | Recorded in the case records | Intrapartum |
| Difference in number of 3rd or 4th-degree perineal tears | Assess by the midwife/doctor suturing the tear. | Within 2 hours after birth |
| Copenhagen University Hospital, Hvidovre | Copenhagen | Denmark |
|
| Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark |
|
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |