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Peripartum outcomes after combined myo-inositol, probiotics, micronutrient supplementation from preconception: NiPPeR RCT: the NiPPeR randomized controlled trial

Peripartum outcomes after combined myo-inositol, probiotics, micronutrient supplementation from preconception: NiPPeR RCT: the NiPPeR randomized controlled trial
Peripartum outcomes after combined myo-inositol, probiotics, micronutrient supplementation from preconception: NiPPeR RCT: the NiPPeR randomized controlled trial
Background: evidence that nutritional supplementation before and during pregnancy improves peripartum outcomes is sparse. In the Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health (NiPPeR) trial, we previously reported that a combined myo-inositol, probiotics, and micronutrient supplement started at preconception showed no difference in the primary outcome of gestational glycemia, but did reduce the risk of preterm delivery, preterm prelabor rupture of membranes, and major postpartum hemorrhage.

Objective: this study aimed to examine the hypothesis that a reduction in major postpartum hemorrhage following a combined nutritional (myo-inositol, probiotics, and micronutrients) intervention is linked with promotion of labor progress and reduced operative delivery.

Study design: this double-blind randomized controlled trial recruited 1729 women from the United Kingdom, Singapore, and New Zealand, aged 18 to 38 years, and planning conception between 2015 and 2017. The effects of the nutritional intervention compared with those of a standard micronutrient supplement (control), taken at preconception and throughout pregnancy, were examined for the secondary outcomes of peripartum events using multinomial, Poisson, and linear regression adjusting for site, ethnicity, and important covariates.

Results: of the women who conceived and progressed beyond 24 weeks’ gestation with a singleton pregnancy (n=589), 583 (99%) provided peripartum data. Between women in the intervention (n=293) and control (n=290) groups, there were no differences in rates of labor induction, oxytocin augmentation during labor, instrumental delivery, perineal trauma, and intrapartum cesarean delivery. Although duration of the first stage of labor was similar, the second-stage duration was 20% shorter in the intervention than in the control group (adjusted mean difference, −12.0 [95% confidence interval, −22.2 to −1.2] minutes; P=.029), accompanied by a reduction in operative delivery for delayed second-stage progress (adjusted risk ratio, 0.61 [0.48–0.95]; P=.022). Estimated blood loss was 10% lower in the intervention than in the control group (adjusted mean difference, −35.0 [−70.0 to −3.5] mL; P=.047), consistent with previous findings of reduced postpartum hemorrhage.

Conclusion: supplementation with a specific combination of myo-inositol, probiotics, and micronutrients started at preconception and continued in pregnancy reduced the duration of the second stage of labor, the risk of operative delivery for delay in the second stage, and blood loss at delivery.
assisted delivery, blood loss, cesarean delivery, delay in second stage of labor, delivery outcomes, instrumental delivery, labor progress, operative delivery, postpartum hemorrhage, pregnancy
0002-9378
Chan, Shiao-Yng
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Yong, Hannah E.J.
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Chan, Hsin Fang
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Barton, Sheila
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Galani, Sevasti
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Zhang, Han
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El-Heis, Sarah
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Wong, Jui-Tsung
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Ong, Judith
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Ebreo, Marilou
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Kenealy, Timothy
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Nield, Heidi
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Baker, Philip N.
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Chong, Yap-Seng
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Cutfield, Wayne
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Godfrey, Keith
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NiPPeR Study Group
Chan, Shiao-Yng
3c9d8970-2cc4-430a-86a7-96f6029a5293
Yong, Hannah E.J.
9d6a310c-8309-4d94-9dd2-7766cb0420ac
Chan, Hsin Fang
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Barton, Sheila
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Galani, Sevasti
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Zhang, Han
be995ae3-ca78-4f48-a3cf-02ed7ed20710
El-Heis, Sarah
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Wong, Jui-Tsung
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Ong, Judith
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Ebreo, Marilou
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Kenealy, Timothy
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Nield, Heidi
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Baker, Philip N.
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Chong, Yap-Seng
7043124b-e892-4d4b-8bb7-6d35ed94e136
Cutfield, Wayne
a01589bd-5b82-49fa-89e1-137e6f59e24d
Godfrey, Keith
0931701e-fe2c-44b5-8f0d-ec5c7477a6fd

Chan, Shiao-Yng, Yong, Hannah E.J. and Chan, Hsin Fang , NiPPeR Study Group (2022) Peripartum outcomes after combined myo-inositol, probiotics, micronutrient supplementation from preconception: NiPPeR RCT: the NiPPeR randomized controlled trial. American Journal of Obstetrics and Gynecology, 4 (6), [100714]. (doi:10.1016/j.ajogmf.2022.100714).

Record type: Article

Abstract

Background: evidence that nutritional supplementation before and during pregnancy improves peripartum outcomes is sparse. In the Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health (NiPPeR) trial, we previously reported that a combined myo-inositol, probiotics, and micronutrient supplement started at preconception showed no difference in the primary outcome of gestational glycemia, but did reduce the risk of preterm delivery, preterm prelabor rupture of membranes, and major postpartum hemorrhage.

Objective: this study aimed to examine the hypothesis that a reduction in major postpartum hemorrhage following a combined nutritional (myo-inositol, probiotics, and micronutrients) intervention is linked with promotion of labor progress and reduced operative delivery.

Study design: this double-blind randomized controlled trial recruited 1729 women from the United Kingdom, Singapore, and New Zealand, aged 18 to 38 years, and planning conception between 2015 and 2017. The effects of the nutritional intervention compared with those of a standard micronutrient supplement (control), taken at preconception and throughout pregnancy, were examined for the secondary outcomes of peripartum events using multinomial, Poisson, and linear regression adjusting for site, ethnicity, and important covariates.

Results: of the women who conceived and progressed beyond 24 weeks’ gestation with a singleton pregnancy (n=589), 583 (99%) provided peripartum data. Between women in the intervention (n=293) and control (n=290) groups, there were no differences in rates of labor induction, oxytocin augmentation during labor, instrumental delivery, perineal trauma, and intrapartum cesarean delivery. Although duration of the first stage of labor was similar, the second-stage duration was 20% shorter in the intervention than in the control group (adjusted mean difference, −12.0 [95% confidence interval, −22.2 to −1.2] minutes; P=.029), accompanied by a reduction in operative delivery for delayed second-stage progress (adjusted risk ratio, 0.61 [0.48–0.95]; P=.022). Estimated blood loss was 10% lower in the intervention than in the control group (adjusted mean difference, −35.0 [−70.0 to −3.5] mL; P=.047), consistent with previous findings of reduced postpartum hemorrhage.

Conclusion: supplementation with a specific combination of myo-inositol, probiotics, and micronutrients started at preconception and continued in pregnancy reduced the duration of the second stage of labor, the risk of operative delivery for delay in the second stage, and blood loss at delivery.

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NiPPeR peripartum AJOG_MFM_blinded submitted_clean - Accepted Manuscript
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Accepted/In Press date: 8 August 2022
e-pub ahead of print date: 13 August 2022
Published date: 1 November 2022
Additional Information: Funding received: Medical Research Council (MRC) Lifecourse Epidemiology Centre, University of Southampton, United Kingdom: Caroline E. Childs (C.E.Childs@soton.ac.uk), Cyrus Cooper (cc@mrc.soton.ac.uk), Paula Costello (pc@mrc.soton.ac.uk), Vanessa Cox (vac@mrc.soton.ac.uk), Nicholas C. Harvey (nch@mrc.soton.ac.uk), Hazel M. Inskip (hmi@mrc.soton.ac.uk).
Keywords: assisted delivery, blood loss, cesarean delivery, delay in second stage of labor, delivery outcomes, instrumental delivery, labor progress, operative delivery, postpartum hemorrhage, pregnancy

Identifiers

Local EPrints ID: 469510
URI: http://eprints.soton.ac.uk/id/eprint/469510
ISSN: 0002-9378
PURE UUID: 387a4fda-b7f9-4b35-9d9e-f80ed8bdfa21
ORCID for Sheila Barton: ORCID iD orcid.org/0000-0003-4963-4242
ORCID for Sarah El-Heis: ORCID iD orcid.org/0000-0003-4277-7187
ORCID for Keith Godfrey: ORCID iD orcid.org/0000-0002-4643-0618

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Date deposited: 16 Sep 2022 16:40
Last modified: 18 Mar 2024 03:31

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Contributors

Author: Shiao-Yng Chan
Author: Hannah E.J. Yong
Author: Hsin Fang Chan
Author: Sheila Barton ORCID iD
Author: Sevasti Galani
Author: Han Zhang
Author: Sarah El-Heis ORCID iD
Author: Jui-Tsung Wong
Author: Judith Ong
Author: Marilou Ebreo
Author: Timothy Kenealy
Author: Heidi Nield
Author: Philip N. Baker
Author: Yap-Seng Chong
Author: Wayne Cutfield
Author: Keith Godfrey ORCID iD
Corporate Author: NiPPeR Study Group

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