No registrations found.
ID
Source
Brief title
Health condition
Cesarean section, keizersnede
Vaginal delivery, vaginale partus
Intestinal colonization, intestinal kolonisatie
Microbiota, microbioom
Antibiotics, antibiotica
Sponsors and support
Intervention
Outcome measures
Primary outcome
ƒ{1. To describe and compare intestinal microbiome colonisation (by means of IS-pro) of neonates born by cesarean section, in terms of timimng of antibiotics treatment: prior to caesarean section (NVOG protocol) or after clamping of the umbilical cord (currently used protocol).
Secondary outcome
ƒ{-To describe and compare intestinal microbiome colonisation of vaginally delivered neonates with those born by caesarean section by means of IS-pro analysis.
- To evaluate effects of maternal vaginal and rectal microbiota composition on neonatal gut microbiota colonisation.
Study objective
Timing of antibiotic administration during a cesarean section (prior to the cesarean section versus after clamping the cord) has a significant influence on the diversity of the developing neonatal intestinal microbiota and presence of specific bacterial species.
Study design
- Postnatal age 0 (day of birth)
- Postnatal age 7 days
- Postnatal age 28 days
Intervention
- 20 women will be treated according the current protocol on antibiotic administration (antibiotic administration after clampsing of the umbilical cord);
- 20 women will be treated according to the NVOG protocol (administration of antibiotics just prior to skin incision)
- 20 women admitted for outpatient vaginal delivery will be asked to participate in this study (providing baseline characteristics)
From each participating woman, one rectal swab and one vaginal swab will be collected closely prior to delivery.
Directly after delivery, oneoral swab will be collected from the neonate. In addition, neonatal fecal samples will be collected on the 1st, 7th and 28th day after birth. Antibiotic levels will be determined from the umbilical cord blood from women assigned to the antibiotic administration prior to skin incision
P.O. Box 7057
J.I.P. Vries, de
Amsterdam 1007 MB
The Netherlands
JIP.deVries@VUMC.nl
P.O. Box 7057
J.I.P. Vries, de
Amsterdam 1007 MB
The Netherlands
JIP.deVries@VUMC.nl
Inclusion criteria
Mother:
- Delivery at a gestational age > 36+6 weeks
- Vaginal or primary cesarean delivery
- Written informed consent
Exclusion criteria
Mother:
- Age < 18 years
- Antibiotic use during pregnancy
- Usage of immunosuppresive drugs up to 3 months prior to delivery
- BMI > 30
- Inflammatory bowel diseases, celiac disease
- Major gastro-intestinal operation in the past (e.g. bowel resection, gastric bypass)
- Diabetes mellitus type1 and 2, and gestational diabetes mellitus insuline dependent)
- intoxications (smoking, alcohol or drugs)
Exclusion after delivery
Mother
- Antibiotic use during first month
Neonate
- Antibiotic use during first month
- Usage of immunosuppresive drugs during first month
- Congenital gastro-intestinal disease
- Gastro-intestinal operation during first month
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5845 |
| NTR-old | NTR6000 |
| Other | : 2014.468 |