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Een gerandomiseerde studie naar epidurale analgesie bij aterme barende vrouwen.

The Randomised Epidural Analgesia in Term delivering women trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25936
Enrollment
200
Registered
2009-04-01
Start date
2008-09-01
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

Epidural analgesia (EA) is an effective method to reduce labour pain, but is not frequently applied in the Netherlands. In this proposal, we determine the beliefs and characteristics of women about epidural analgesia and we asses the impact of a proactive policy of offering EA at the start of labour as compared to a restrictive policy on maternal pain reduction, obstetrical complications, neonatal outcomes and maternal experience of the delivery. Besides we want to gain insight in the influence

Interventions

Women will be allocated at random into two different groups: 1. EA group. These women are given an EA as soon as possible as they are in labour, judged by the attending gynaecologist and based on an
2. Non-EA (restrictive) group. These women receive pain relief only on their explicit request. According to local preferences, several methods of pain relief are allowed, including EA in case other me
2. MUMC: pethidine, ropivacaïne/sufentanil.

Sponsors

Atrium Medical Centre Parkstad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients in order to be eligible for the trial, women have to: 1. Be 18 years or older; 2. Bear a singleton child in cephalic presentation; 3. Be under supervision (second line) for their pregnancy in one of the participating centres (MUMC, AMCP); 4. Have no contraindications for vaginal labour; 5. Have no contraindications for EA: A. Use of coumarine derivates; B. LMWH in therapeutic dose; C. LMWH in profylactic dose, less than 10 hours ago; D. Thrombocytes < 80 x 109/ L; E. Use of thrombocytes aggregation inhibitors or anamnestic increased bleeding tendency; F. Blood clotting disorders; G. Allergy for used anesthetics; H. Spine disorders or back infection.

Exclusion criteria

Exclusion criteria: Patient in order not to be eligible for the trial, women have to: 1. Be younger than 18 years; 2. Bear twin pregnancy; 3. Have contraindications for vaginal labour; 4. Have contraindications for EA; 5. Referral by midwife during labour (first line).

Design outcomes

Primary

MeasureTime frame
Primary outcome is maternal pain reduction during delivery, as measured on a VAS pain scale.

Secondary

MeasureTime frame
Secondary outcomes are the use of oxytocin, the number of instrumental vaginal deliveries, the number of caesarean sections, the duration of the second stage of labour, maternal hypotension, motor block, urine retention, fever, used antibiotics, used anaesthetics, neonatal condition (including Apgar scores and umbilical blood gasses), maternal experience and quality of life.

Contacts

Public ContactMartine M.L.H. Wassen
martine_wassen@hotmail.com+31 (0)6 45058866

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)