Ritgens Maneuver for the Prevention of Anal Sphincter Tears at Delivery: A Randomized Controlled Trial
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| ClinicalTrials.gov Identifier: NCT00652977 |
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Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : April 7, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Perineal Lacerations | Procedure: Ritgens maneuver Procedure: Standard care (Manual support of the perineum) | Not Applicable |
This application is made retroactively - the study was performed during December 1st, 1999 to July 31st, 2001, at Lund University Hospital and Helsingborg Hospital. Primigravid women in the area were informed about the study at the maternity care centers, receiving written information in gestational week 36. Eligible for the study were women with singleton pregnancy and a fetus in cephalic presentation, admitted for labor, rupture of the membranes or induction after 37 completed gestational weeks. Primigravid women received written information about the study at the maternal health care centers, and eligible women were asked for consent at admission in labor.
Randomization was done at the beginning of the second stage of labor (at full cervical dilatation), in each unit by a telephone call from the delivering midwife to the other department, where randomization lists with numbers for allocation were kept. In women allocated to Ritgen´s maneuver, the protocol stated that the delivery of the fetal head should be managed by this maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The technique for Ritgen´s maneuver was standardized, and midwives that were unfamiliar with the procedure were instructed by senior colleagues before the trial. In the other study group, the protocol entailed our standard care. The standard practice at delivery was using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1623 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Modified Ritgens Maneuver for Perineal Protection at Delivery |
| Study Start Date : | December 1999 |
| Actual Primary Completion Date : | July 2001 |
| Actual Study Completion Date : | July 2001 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: I
The delivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head.
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Procedure: Ritgens maneuver
Delivery of the fetal head should be managed by Ritgens maneuver, i.e. lifting the fetal chin anteriorly, using the fingers of one hand placed between the anus and the coccyx, and thereby extending the fetal neck, whereas the other hand should be placed on the fetal occiput to control the pace of the expulsion of the fetal head. The maneuver was used during a uterine contraction |
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II
Standard care at delivery: Manual support of the perineum
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Procedure: Standard care (Manual support of the perineum)
The protocol entailed our standard care: using one hand to apply pressure against the perineum, and the other hand on the fetal occiput to control the expulsion of the fetal head, and only to use Ritgen´s maneuver in case of labor arrest or abnormal fetal heart rate pattern when the fetal head was at the pelvic floor. |
- Perineal rupture grade III-IV (anal sphincter tears) [ Time Frame: At delivery - within minutes - hours of randomization ]
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| Ages Eligible for Study: | 16 Years to 44 Years (Child, Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Women with singleton pregnancy and a fetus in cephalic presentation
- admitted for labor
- rupture of the membranes or induction after 37 completed gestational weeks
- and reaching full cervical dilatation.
Exclusion Criteria:
- Operative delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652977
| Sweden | |
| Helsingborgs lasarett | |
| Helsingborg, Sweden, 25187 | |
| Lund Univeristy Hospital | |
| Lund, Sweden, 221 85 | |
| Principal Investigator: | Andreas Herbst, MD, PhD | Lund University Hospital |
| Responsible Party: | Andreas Herbst, associate professor, Department of Obstetrics and Gynecology, Lund University Hospital |
| ClinicalTrials.gov Identifier: | NCT00652977 |
| Other Study ID Numbers: |
Lu1-99 |
| First Posted: | April 4, 2008 Key Record Dates |
| Last Update Posted: | April 7, 2008 |
| Last Verified: | April 2008 |
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sphincter tears Ritgen maneuver perineal tears prevention delivery |
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Lacerations Wounds and Injuries |