A randomized, multicentre, open label trial comparing the start of the induction of labor with intravenous oxytocin according to the circadian rhythm with standard care.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22012

Enrollment

400

Registered

2005-08-05

Start date

2003-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of labor with intravenous oxytocin.

Interventions

The women who start with induction of labor in the evening (21.00 hours) are defined as the intervention group. The control group are those women who start in the early morning (07.00 hours). Both

Eligibility

Inclusion criteria

Inclusion criteria: Women are eligible to participate when the clinician judges that it is indicated to induce labor and the cervix is favourable for induction with a drip of oxytocin.

Exclusion criteria

Exclusion criteria: Excluded are women with: 1. Intrauterine fetal death; 2. Maternal age below 18 years; 3. Insufficient understanding of the meaning of the trial; 4. Language problems; 5. Contraindication for amniotomy; 6. Secondary caesarean section in the medical history; 7. Gestational age shorter than 36 weeks; 8. Necessity for timed or immediate intervention because of suspected fetal distress.

Design outcomes

Primary

Measure	Time frame
The definition of the primary outcome is the duration of labor in minutes. For the on protocol analysis in the final analysis of the trial, the duration of labor is defined as the time measured from start of the drip until time of birth of the baby, in case of twins the time of the first baby. For intention to treat analysis, the duration of labor is defined as the time of occupation of the labor room.	—

Measure

Time frame

The definition of the primary outcome is the duration of labor in minutes. For the on protocol analysis in the final analysis of the trial, the duration of labor is defined as the time measured from start of the drip until time of birth of the baby, in case of twins the time of the first baby. For intention to treat analysis, the duration of labor is defined as the time of occupation of the labor room.

—

Secondary

Measure	Time frame
Secondary outcomes are the number of interventions like ventouse, forcipal extraction and caesarean section, number of children with an Apgar score below 7 after 5 minutes, number of intrapartum infections, necessity for pain relief and use of morphine, pethidine or epidural anaesthesia, and the patient satisfaction with quality of care.	—

Contacts

Public ContactJ.J.H. Bakker

Academic Medical Center (AMC), Department of Obstetrics and Gynaecology, H3-107, P.O. Box 22660

j.j.bakker@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)