Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the safety and efficacy of the mother's active pushing during cesarean delivery.
Patients, who are getting a scheduled cesarean section and having no contraindication for valsalva manoeuvres are eligible for this study. The gestational week should be between 37 and 42 weeks. Patients have to provide informed consent to this study. Patients must have epidural anaesthesia. They must understand the German language in order to understand information during cesarean section and correctly fill-out the questionnaires. Emergent cesarean sections or pregnant women known with chronic pain, severe preeclampsia or HELLP-Syndrome will be excluded.
179 patients were initially recruited, of which 79 were excluded. The 100 patients were grouped into two study groups; Conventional and Assisted Groups. The grouping was performed randomly using simple randomization. Based on the findings of Armbrust et al and our clinical experience we expect a therapeutic effect of 20% which results in a mean visual analog scale reduction of 1.2. Applying a two-sided T-Test for independent samples at a significance level of 0.05, a mean difference of 0.8 between the groups and a standard deviation of 2, we need 17 patients per treatment arm to detect a difference between both treatment groups with a power of 80%14. The number of patients per treatment arm was increased to 50 patients to make up for any missing data.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Group | No Intervention | Received a classic CS without intervention (Control group) | |
| Assisted group | Experimental | after uterotomy during CS, the mother was instructed and motivated to push for the delivery of the head and the shoulders of the baby. Simultaneously, the surgical assistant applied fundal pressure to support the mothers pushing if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mother's push during CS | Procedure | after uterotomy, the mother was instructed and motivated to push for the delivery of the head and the shoulders of the baby. Simultaneously, the surgical assistant applied fundal pressure to support the mothers pushing if necessary |
| Measure | Description | Time Frame |
|---|---|---|
| Change in postoperative pain of the mother | Discomfort and pain of the mother were assessed, on a 10-point Likert scale | directly after delivery (intraoperative), 4-6 hours after delivery and on the first and second postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and quality of Breastfeeding | Using the Breastfeeding Self-Efficacy Scale, Short Form (BSES-SF) | Postoperative day 0,1,2 |
| Incidence of Postpartum Depression | Using the Edinburgh Postnatal Depression Scale (EPDS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Peter Hillemanns, Professor | Hannover Medical School | Study Chair |
| Stefan Engeli, Prof. | Hannover medical school (MHH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanover medical school | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Wacker J. Geburtshilfe. Kaiserschnitt vs. Natürliche Geburt. Geburtshilfe Frauenheilkd. 2010;70(10):840-3. | ||
| Background | Beckmann M W, Bader W BI. Finanzierung und finanzielle Probleme von Leistungen und Strukturen im Fachgebiet Gynäkologie und Geburtshilfe im Jahr 2011 - allgemeine Aspekte und geburtshilfliche Versorgung. Geburtsh Frauenheilk. 2011. | ||
| 8818678 | Background | DiMatteo MR, Morton SC, Lepper HS, Damush TM, Carney MF, Pearson M, Kahn KL. Cesarean childbirth and psychosocial outcomes: a meta-analysis. Health Psychol. 1996 Jul;15(4):303-14. doi: 10.1037//0278-6133.15.4.303. | |
| 11359318 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 26, 2020 | Aug 18, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
prospective randomized study
Not provided
Not provided
Not provided
| Postoperative day 0,1,2 |
| senses of participation and control | Using likert scale. To determine the effect of the mother's push on the sense of control and participation. Studies showed that poor communications as well as fears of missing out on the birth are one of the main causes of distress during CS . Improving sense of control and participation will improve the birth experience . | Intraoperative, directly after the baby delivery |
| Different in the operation duration between the two groups | Using the time , that was documented in the operation protocols | At end of the operation |
| Intensity of intraoperative fundal pressure | Using the Likert scale | Intraoperative after the delivery of the baby |
| Quantity of the Intraoperative maternal blood loss | Quantity of blood loss that the surgeon has been estimated | Intraoperative - end of the operation |
| Rate of birth asphyxia | Using APGAR score , PH sampling from umbilical cord (venous and arterial) | Intraoperative , directly after the baby delivery |
| Background |
| Clement S. Psychological aspects of caesarean section. Best Pract Res Clin Obstet Gynaecol. 2001 Feb;15(1):109-26. doi: 10.1053/beog.2000.0152. |
| 18651885 | Background | Smith J, Plaat F, Fisk NM. The natural caesarean: a woman-centred technique. BJOG. 2008 Jul;115(8):1037-42; discussion 1042. doi: 10.1111/j.1471-0528.2008.01777.x. |
| 25572878 | Background | Armbrust R, Hinkson L, von Weizsacker K, Henrich W. The Charite cesarean birth: a family orientated approach of cesarean section. J Matern Fetal Neonatal Med. 2016;29(1):163-8. doi: 10.3109/14767058.2014.991917. Epub 2015 Jan 9. |
| 21856077 | Background | Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005. |
| 9472218 | Background | Bergant AM, Nguyen T, Heim K, Ulmer H, Dapunt O. [German language version and validation of the Edinburgh postnatal depression scale]. Dtsch Med Wochenschr. 1998 Jan 16;123(3):35-40. doi: 10.1055/s-2007-1023895. German. |
| 14649593 | Background | Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459. |
| Background | Sitter-Trollmann P. " Stillen und Selbstwirksamkeit - ein Beitrag zur präventiven Erfassung von Stillproblemen durch standardisierte Instrumente ". 2011;147. Available from: http://othes.univie.ac.at/16715/ |
| 28180019 | Background | Vaziri F, Arzhe A, Asadi N, Pourahmad S, Moshfeghy Z. Spontaneous Pushing in Lateral Position versus Valsalva Maneuver During Second Stage of Labor on Maternal and Fetal Outcomes: A Randomized Clinical Trial. Iran Red Crescent Med J. 2016 Aug 10;18(10):e29279. doi: 10.5812/ircmj.29279. eCollection 2016 Oct. |
| 11464348 | Background | Siddik SM, Aouad MT, Jalbout MI, Rizk LB, Kamar GH, Baraka AS. Diclofenac and/or propacetamol for postoperative pain management after cesarean delivery in patients receiving patient controlled analgesia morphine. Reg Anesth Pain Med. 2001 Jul-Aug;26(4):310-5. doi: 10.1053/rapm.2001.21828. |
| 39601809 | Derived | Sayed A, Sayed AA, Fard D, Hillemanns P, Von Kaisenberg C, Klapdor R. Effect of mother's active pushing at cesarean delivery: a randomized controlled trial. Arch Gynecol Obstet. 2025 Mar;311(3):599-607. doi: 10.1007/s00404-024-07835-1. Epub 2024 Nov 27. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |