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Antepartum Membrane Stripping in GBS Carriers, Is It Safe? (The STRIP-G Study).

Kabiri D, Hants Y, Yarkoni TR, Shaulof E, Friedman SE, Paltiel O, Nir-Paz R, Aljamal WE, Ezra Y - PLoS ONE (2015)

Bottom Line: We compared the incidence of composite adverse neonatal outcomes (primary outcome) among the three study groups, while secondary outcome measure was composite adverse maternal outcomes.GBS-Negative groups 0.67 (95%, CI = 0.30-1.50)); while composite adverse maternal outcomes occurred in 9 (6.66%), 31 (8.59%), and 5 (10.87%) in the GBS-positive, GBS-negative, and unknown groups, respectively (P = 0.617).Antepartum membrane stripping in GBS carriers appears to be a safe obstetrical procedure that does not adversely affect maternal or neonatal outcomes.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.

ABSTRACT

Objective: Stripping of the membranes is an established and widely utilized obstetric procedure associated with higher spontaneous vaginal delivery rates, reduced need for formal induction of labor and a lower likelihood of post-term pregnancy. Due to the theoretical concern of bacterial seeding during the procedure many practitioners choose not to sweep the membranes in Group B Streptococcus (GBS) colonized patients. We conducted 'the STRIP-G study' in order to determine whether maternal and neonatal outcomes are affected by GBS carrier status in women undergoing membrane stripping.

Study design: We conducted a prospective study in a tertiary referral center, comparing maternal and neonatal outcomes following membrane stripping among GBS-positive, GBS-negative, and GBS-unknown patients. We compared the incidence of composite adverse neonatal outcomes (primary outcome) among the three study groups, while secondary outcome measure was composite adverse maternal outcomes.

Results: A total of 542 women were included in the study, of which 135 were GBS-positive, 361 GBS-negative, and 46 GBS-unknown status. Demographic, obstetric, and intra-partum characteristics were similar for all groups. Adverse neonatal outcomes were observed in 8 (5.9%), 31 (8.6%), and 2 (4.3%) in the GBS-positive, GBS-negative, and unknown groups, respectively (P = 0.530), (Odds Ratio between GBS-Positive vs. GBS-Negative groups 0.67 (95%, CI = 0.30-1.50)); while composite adverse maternal outcomes occurred in 9 (6.66%), 31 (8.59%), and 5 (10.87%) in the GBS-positive, GBS-negative, and unknown groups, respectively (P = 0.617).

Conclusions: Antepartum membrane stripping in GBS carriers appears to be a safe obstetrical procedure that does not adversely affect maternal or neonatal outcomes.

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Related in: MedlinePlus

Clinical Indicators Of Possible-Early-Onset Neonatal Infection.(Figure reproduced from “Antibiotics for early-onset neonatal infection”, NICE clinical guidelines 149, 2012).
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pone.0145905.g001: Clinical Indicators Of Possible-Early-Onset Neonatal Infection.(Figure reproduced from “Antibiotics for early-onset neonatal infection”, NICE clinical guidelines 149, 2012).

Mentions: We did not choose early-onset neonatal GBS sepsis as the primary outcomes because the rarity of this event (incidence of 0.17–0.3 cases per 1000 births), that renders the assumption of bacterial seeding during membrane stripping difficult to demonstrate, and it is almost impossible to design a well-powered study that would be able to achieve statistical significance by using neonatal GBS sepsis as a primary endpoint. Following the assumption that a healthy neonate would not progress directly from a perfect state of health to full blown neonatal sepsis, the STRIP-G specialist group (which includes expert in perinatology, neonatology, microbiology and epidemiology), constructed a formal and structured scale aiming to detect a “compromised neonate” as a surrogate primary endpoint, based on the NICE criteria for early detection of neonatal sepsis [20]. The NICE criteria are produced by the National Institute for Health and Care Excellence in the United Kingdom to guide practitioners regarding which neonates should receive antibiotics for suspected early-onset GBS infection. According to the NICE guidelines, clinical indicators of possible early-onset neonatal infection include 19 clinical indicators and 4 ‘red flags’ indicators (Fig 1). Therefore, we performed a systematic review of medical records for each neonate whose mother participated in the study in order to identify any “compromised neonate”, defined as the presence of at least one ‘red flag’ or two clinical indicators of possible early-onset neonatal infection [20].


Antepartum Membrane Stripping in GBS Carriers, Is It Safe? (The STRIP-G Study).

Kabiri D, Hants Y, Yarkoni TR, Shaulof E, Friedman SE, Paltiel O, Nir-Paz R, Aljamal WE, Ezra Y - PLoS ONE (2015)

Clinical Indicators Of Possible-Early-Onset Neonatal Infection.(Figure reproduced from “Antibiotics for early-onset neonatal infection”, NICE clinical guidelines 149, 2012).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4697801&req=5

pone.0145905.g001: Clinical Indicators Of Possible-Early-Onset Neonatal Infection.(Figure reproduced from “Antibiotics for early-onset neonatal infection”, NICE clinical guidelines 149, 2012).
Mentions: We did not choose early-onset neonatal GBS sepsis as the primary outcomes because the rarity of this event (incidence of 0.17–0.3 cases per 1000 births), that renders the assumption of bacterial seeding during membrane stripping difficult to demonstrate, and it is almost impossible to design a well-powered study that would be able to achieve statistical significance by using neonatal GBS sepsis as a primary endpoint. Following the assumption that a healthy neonate would not progress directly from a perfect state of health to full blown neonatal sepsis, the STRIP-G specialist group (which includes expert in perinatology, neonatology, microbiology and epidemiology), constructed a formal and structured scale aiming to detect a “compromised neonate” as a surrogate primary endpoint, based on the NICE criteria for early detection of neonatal sepsis [20]. The NICE criteria are produced by the National Institute for Health and Care Excellence in the United Kingdom to guide practitioners regarding which neonates should receive antibiotics for suspected early-onset GBS infection. According to the NICE guidelines, clinical indicators of possible early-onset neonatal infection include 19 clinical indicators and 4 ‘red flags’ indicators (Fig 1). Therefore, we performed a systematic review of medical records for each neonate whose mother participated in the study in order to identify any “compromised neonate”, defined as the presence of at least one ‘red flag’ or two clinical indicators of possible early-onset neonatal infection [20].

Bottom Line: We compared the incidence of composite adverse neonatal outcomes (primary outcome) among the three study groups, while secondary outcome measure was composite adverse maternal outcomes.GBS-Negative groups 0.67 (95%, CI = 0.30-1.50)); while composite adverse maternal outcomes occurred in 9 (6.66%), 31 (8.59%), and 5 (10.87%) in the GBS-positive, GBS-negative, and unknown groups, respectively (P = 0.617).Antepartum membrane stripping in GBS carriers appears to be a safe obstetrical procedure that does not adversely affect maternal or neonatal outcomes.

View Article: PubMed Central - PubMed

Affiliation: Department of Obstetrics and Gynecology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel.

ABSTRACT

Objective: Stripping of the membranes is an established and widely utilized obstetric procedure associated with higher spontaneous vaginal delivery rates, reduced need for formal induction of labor and a lower likelihood of post-term pregnancy. Due to the theoretical concern of bacterial seeding during the procedure many practitioners choose not to sweep the membranes in Group B Streptococcus (GBS) colonized patients. We conducted 'the STRIP-G study' in order to determine whether maternal and neonatal outcomes are affected by GBS carrier status in women undergoing membrane stripping.

Study design: We conducted a prospective study in a tertiary referral center, comparing maternal and neonatal outcomes following membrane stripping among GBS-positive, GBS-negative, and GBS-unknown patients. We compared the incidence of composite adverse neonatal outcomes (primary outcome) among the three study groups, while secondary outcome measure was composite adverse maternal outcomes.

Results: A total of 542 women were included in the study, of which 135 were GBS-positive, 361 GBS-negative, and 46 GBS-unknown status. Demographic, obstetric, and intra-partum characteristics were similar for all groups. Adverse neonatal outcomes were observed in 8 (5.9%), 31 (8.6%), and 2 (4.3%) in the GBS-positive, GBS-negative, and unknown groups, respectively (P = 0.530), (Odds Ratio between GBS-Positive vs. GBS-Negative groups 0.67 (95%, CI = 0.30-1.50)); while composite adverse maternal outcomes occurred in 9 (6.66%), 31 (8.59%), and 5 (10.87%) in the GBS-positive, GBS-negative, and unknown groups, respectively (P = 0.617).

Conclusions: Antepartum membrane stripping in GBS carriers appears to be a safe obstetrical procedure that does not adversely affect maternal or neonatal outcomes.

Show MeSH
Related in: MedlinePlus