Perineal Lacerations Clinical Trial
Official title:
Modified Ritgens Maneuver for Perineal Protection at Delivery
The aim of the investigation was to assess whether routine use of the modified Ritgen´s maneuver decreases the risk of anal sphincter injury at delivery, compared with simple manual protection of the perineum.Ritgen´s maneuver means that the fetal chin is reached for between the anus and the coccyx and pulled anteriorly, while using the fingers of the other hand on the fetal occiput to control speed of delivery and keep flexion of the fetal neck.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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