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This study investigates efficacy, safety and childbirth experience in women receiving pudendal block during the final stage of delivery. It is an observational study and half of included primarous women recieve a pudendal block.
Pudendal block is used when there is a need to alleviate pain in the final stage of labour:
Pudendal block is provided by inserting a needle close to the pudendal nerve that runs through the pelvis and innervates the perineal area.Pudendal block is an old and relatively simple method, but not well studied. The main aim is to study pudendal nerve block as pain relief in final stage of labour for primiparous women delivering vaginally.
The investigators aim to investigate whether possible adverse effects may outweigh the positive analgesic effect in the final stage of labour, or the opposite. The ASL (Analgesia in the Second stage of Labour) study may fill knowledge gaps and add important knowledge regarding pain relief during the final stage of childbirth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed | Pudendal nerve block provided |
| |
| Not exposed | Pudendal nerve block is NOT provided |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pudendal nerve block | Procedure | Pudendal nerve block provided during last fase of delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Childbirth experience | Childbirth experience questionnaire (CEQ), total score on a scale from 1.0 to 4.0. Higher score means better experience. | Responds to questionnaire 4-12 weeks after delivery. |
| Urinary retention | Urinary retention after delivery defined as inability to void and need for catheterization within 3 hours. | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, obstetric | Measured by Visual Analog Scale (VAS). Scale from 0 to 100, higher scpre means more pain. | Responds to questionnaire 4-12 weeks after delivery. |
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Inclusion Criteria:
Exclusion Criteria:
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The participants is selected from 2 delivery units at Oslo Univeristy Hospital (OUH) in Oslo, Norway. OUH is a third referral hospital, the largest Obstetrics Dept. in Norway, and accounting for 1/6 of all deliveries in Norway (9600 deliveries/year).
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| Name | Affiliation | Role |
|---|---|---|
| Anne Flem Jacobsen, PhD | Univeristy of Oslo | Principal Investigator |
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Anonymous individual participant data for the primary outcome measures will be made available on request, when the study is finished. Access to data will be restricted due to sensitive nature of the data, but will be shared if asked for within the anonymous data restriction imposed by the patient consent and ethical body approval.
Data will be available on request within 1 year after study completion.
Data access will be considered on specific request. Requestors wil be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| D010549 | Personal Satisfaction |
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |