|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 1, 2008 | ||||
| Last Updated Date | April 4, 2008 | ||||
| Start Date ICMJE | December 1999 | ||||
| Primary Completion Date | July 2001 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Perineal rupture grade III-IV (anal sphincter tears) [ Time Frame: At delivery - within minutes - hours of randomization ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00652977 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Ritgens Maneuver for the Prevention of Anal Sphincter Tears at Delivery: A Randomized Controlled Trial | ||||
| Official Title ICMJE | Modified Ritgens Maneuver for Perineal Protection at Delivery | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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 Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Open Label, Parallel Assignment | ||||
| Condition ICMJE | Perineal Lacerations | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups |
|
||||
| Publications * | Jönsson ER, Elfaghi I, Rydhström H, Herbst A. Modified Ritgen's maneuver for anal sphincter injury at delivery: a randomized controlled trial. Obstet Gynecol. 2008 Aug;112(2 Pt 1):212-7. | ||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1623 | ||||
| Completion Date | July 2001 | ||||
| Primary Completion Date | July 2001 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Female | ||||
| Ages | 16 Years to 44 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00652977 | ||||
| Responsible Party | Andreas Herbst, associate professor, Department of Obstetrics and Gynecology, Lund University Hospital | ||||
| Study ID Numbers ICMJE | Lu1-99 | ||||
| Study Sponsor ICMJE | Lund University Hospital | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Lund University Hospital | ||||
| Verification Date | April 2008 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||