PregnancyMaNuNCT07550309
Longitudinal Randomized Controlled Study on the Effectiveness of Nutritional Education During Uncomplicated Pregnancy
A study testing Structured Nutritional Education Program and Routine Prenatal Care With Nutritional Information Brochure in people with Pregnancy and Uncomplicated Pregnancy, run by Azienda Sanitaria Locale CN2 Alba-Bra at 1 site in Italy.
Trial summary
The goal of this clinical trial is to evaluate whether a structured nutritional education intervention can improve gestational weight gain outcomes and related maternal and neonatal health indicators in women with uncomplicated pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Uncomplicated Pregnancy, Diet, Food and Nutrition
- What is being tested?
- Structured Nutritional Education Program and Routine Prenatal Care With Nutritional Information Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteItaly
- Study dates
- 13 Feb 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women with gestational age ≤ 17 weeks at enrollment
- Age ≥ 18 years
- Ability to provide written informed consent
- Availability of a personal smartphone for study participation and data reporting
- Availability of a personal weight scale for home monitoring
Who cannot join
- Multiple pregnancy
- Pre-existing hypertension
- Pre-existing diabetes mellitus
- Pre-pregnancy body mass index (BMI) < 18.5 kg/m²
- Pre-pregnancy body mass index (BMI) ≥ 35 kg/m²
- History of psychiatric disorders
Show all 11Show fewer
- Overt hypothyroidism or hyperthyroidism
- Celiac disease
- Inflammatory bowel disease (ulcerative colitis or Crohn's disease)
- History of bariatric surgery
- Language barrier preventing comprehension of study procedures or completion of assessments
Trial locations and contacts
1 site in 1 country.
Italy1 site
SC Nutrizione Clinica e Disturbi del Comportamento Alimentare ASL CN2, Italy
Verduno, CN, 12060
About this study
Official title: Longitudinal, Randomized, Parallel-Group, Controlled Clinical Study to Evaluate the Effectiveness of a Nutritional Education Intervention in Uncomplicated Pregnancy
The goal of this clinical trial is to evaluate whether a structured nutritional education intervention can improve gestational weight gain outcomes and related maternal and neonatal health indicators in women with uncomplicated pregnancy. The main question it aims to answer is whether a group-based nutritional education program increases the proportion of women achieving gestational weight gain within Institute of Medicine (IOM) recommended ranges compared with standard prenatal care.
Researchers will compare a structured nutritional education intervention group to a control group receiving routine prenatal care and a nutritional information brochure to see if the intervention improves gestational weight gain within recommended ranges and affects maternal and neonatal outcomes.
Read more
Participants in the intervention group will:
- Attend three weekly group-based nutritional education sessions delivered by trained healthcare professionals
- Attend one practical cooking (show-cooking) session
Participants in the control group will:
- Receive routine prenatal care and a written nutritional information brochure
- Be followed from early pregnancy until 8 weeks postpartum
All participants (including control group) will:
- Record body weight regularly throughout pregnancy using a telemedicine system
- Complete questionnaires on dietary intake and quality of life at multiple time points
- Undergo assessments of body composition and urinary biomarkers of oxidative stress during pregnancy
Read the detailed description
This study is based on the hypothesis that dietary behavior during pregnancy plays a key role in determining maternal metabolic adaptation and pregnancy outcomes, particularly through its influence on gestational weight gain regulation and oxidative stress balance.
Pregnancy is characterized by physiological metabolic and endocrine adaptations that increase susceptibility to both under- and over-nutrition. Inadequate dietary patterns may contribute to excessive gestational weight gain, which has been associated with increased risk of maternal and neonatal complications. Conversely, nutritional imbalance may also affect fetal development and long-term health trajectories. Despite existing recommendations for healthy eating during pregnancy, adherence in real-world settings remains suboptimal, suggesting the need for structured behavioral interventions.
In addition to metabolic effects, pregnancy is associated with a physiological increase in oxidative stress, which is involved in placental development and fetal growth regulation. However, excessive oxidative stress has been linked to adverse outcomes including impaired placental function and increased risk of metabolic and hypertensive disorders. Dietary patterns rich in antioxidants, such as those emphasizing high-quality nutrients and balanced macronutrient intake, may contribute to modulating oxidative stress pathways.
The intervention tested in this study is grounded in behavioral nutrition and health education principles, with the aim of improving dietary awareness, food selection skills, and long-term adherence to nutritional recommendations. The group-based format is designed to enhance engagement, facilitate peer interaction, and improve cost-effectiveness compared to individual counseling approaches.
The study employs a randomized controlled design to minimize selection bias and allow causal inference regarding the effect of the intervention. Stratified randomization is used to ensure balance across clinically relevant prognostic factors, including pre-pregnancy BMI and parity, which are known to influence gestational weight gain and pregnancy outcomes.
The longitudinal structure of the study allows evaluation of both short-term behavioral changes during pregnancy and medium-term maternal outcomes extending into the postpartum period. The integration of behavioral, anthropometric, and biochemical assessments enables a multidimensional evaluation of the intervention's impact.
- Conditions
- Pregnancy, Uncomplicated Pregnancy, Diet, Food and Nutrition, Weight Gain During Pregnancy, Oxidative Stress, Nutrition Therapy
- Being tested
- Structured Nutritional Education Program, Routine Prenatal Care With Nutritional Information Brochure
- Keywords
- Nutritional education in pregnancy, Group-based dietary intervention, Gestational weight gain, Uncomplicated pregnancy, Randomized controlled trial, Prenatal nutrition counseling, Maternal diet intervention, Dietary behavior change in pregnancy, Oxidative stress in pregnancy, Pregnancy weight management, Telemedicine weight monitoring, Pregnancy
- Medical subject headings
- Gestational Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Nutritional Education ProgramBehavioural
Participants receive a structured group-based nutritional education program delivered during pregnancy by trained healthcare professionals. The program includes three weekly group educational sessions and one practical cooking (show-cooking) session. The intervention focuses on improving knowledge and practical skills related to healthy dietary patterns during pregnancy, nutrient intake, and gestational weight management.
Routine Prenatal Care With Nutritional Information BrochureOther
Participants receive routine prenatal care according to standard clinical practice. In addition, they are provided with a written nutritional information brochure containing general dietary recommendations for pregnancy. No structured educational sessions or group-based interventions are delivered in this arm.
| Study group | Role | What they receive |
|---|---|---|
| Structured Nutritional Education Intervention | Experimental | Participants receive a structured group-based nutritional education program delivered during pregnancy by trained healthcare professionals. The intervention includes group educational sessions focused on healthy dietary patterns during pregnancy, nutrient requirements, meal planning, and gestational weight management, plus one practical cooking (show-cooking) session. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the control arm. Receives: Behavioral: Structured Nutritional Education Program |
| Routine Care + Brochure | Active comparator | Participants receive routine prenatal care according to standard clinical practice. In addition, they are provided with a written nutritional information brochure containing general dietary recommendations for pregnancy. This arm serves as the control condition for comparison with the structured nutritional education intervention. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the intervention arm. Receives: Other: Routine Prenatal Care With Nutritional Information Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges
This outcome assesses the proportion of participants whose total gestational weight gain falls within the Institute of Medicine (IOM) recommended ranges according to pre-pregnancy body mass index (BMI) categories. Pre-pregnancy BMI is used to classify recommended weight gain ranges, and total gestational weight gain is evaluated at the end of pregnancy.
Measured: From enrollment (12-17 weeks of gestation) to delivery.
Secondary outcomes (8)
Change in Urinary Oxidative Stress Biomarkers During Pregnancy
This outcome evaluates changes in oxidative stress status during pregnancy by measuring urinary levels of isoprostanes and malondialdehyde, as well as total antioxidant capacity, using validated laboratory assays.
Measured: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Dietary Intake During Pregnancy
This outcome assesses changes in dietary intake, including energy intake and macronutrient distribution (carbohydrates, proteins, fats including saturated and unsaturated fatty acids, and dietary fiber), measured using a validated food frequency questionnaire.
Measured: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Maternal Quality of Life During Pregnancy
This outcome evaluates changes in maternal quality of life using the WHOQOL-BREF questionnaire and the number of self-reported healthy days.
Measured: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Maternal Body Composition During Pregnancy
This outcome measures changes in maternal body composition assessed by bioelectrical impedance analysis.
Measured: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Gestational Weight Gain Rate Within Institute of Medicine Recommendations
This outcome evaluates the weekly rate of gestational weight gain according to Institute of Medicine (IOM) recommendations based on pre-pregnancy BMI.
Measured: From enrollment (12-17 weeks of gestation) to delivery.
Incidence of Maternal Pregnancy Complications
This outcome assesses the incidence of gestational diabetes mellitus, hypertensive disorders of pregnancy (including preeclampsia/eclampsia), and preterm birth.
Measured: From enrollment (12-17 weeks of gestation) to delivery.
Incidence of Neonatal Complications
This outcome evaluates neonatal outcomes including macrosomia and small-for-gestational-age infants.
Measured: At delivery.
Postpartum Maternal Weight Change
This outcome assesses maternal weight change at 8 weeks postpartum compared with pre-pregnancy weight.
Measured: From delivery to 8 weeks postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start13 Feb 2023
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to either a structured nutritional education intervention group or a control group receiving routine prenatal care with provision of a nutritional information brochure. The study uses a parallel-group design, with each participant assigned to a single study arm and followed longitudinally throughout pregnancy and up to 8 weeks postpartum. Randomization is stratified according to pre-pregnancy body mass index (BMI) categories and parity, using permuted blocks to ensure balance between groups.
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-Bra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cloè Dalla Costa, Principal investigator, SC Nutrizione Clinica e Disturbi del Comportamento Alimentare, Ospedale Michele e Pietro Ferrero, ASL CN2, Verduno (CN), Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550309
- Sponsor's protocol ID
- MaNu
- Acronym
- MaNu
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simon-Szabo Z, Fogarasi E, Nemes-Nagy E, Denes L, Croitoru M, Szabo B. Oxidative stress and peripartum outcomes (Review). Exp Ther Med. 2021 Jul;22(1):771. doi: 10.3892/etm.2021.10203. Epub 2021 May 17.
PubMed 34055070Santander Ballestin S, Gimenez Campos MI, Ballestin Ballestin J, Luesma Bartolome MJ. Is Supplementation with Micronutrients Still Necessary during Pregnancy? A Review. Nutrients. 2021 Sep 8;13(9):3134. doi: 10.3390/nu13093134.
PubMed 34579011Marshall NE, Abrams B, Barbour LA, Catalano P, Christian P, Friedman JE, Hay WW Jr, Hernandez TL, Krebs NF, Oken E, Purnell JQ, Roberts JM, Soltani H, Wallace J, Thornburg KL. The importance of nutrition in pregnancy and lactation: lifelong consequences. Am J Obstet Gynecol. 2022 May;226(5):607-632. doi: 10.1016/j.ajog.2021.12.035. Epub 2021 Dec 27.
PubMed 34968458Hussain T, Murtaza G, Metwally E, Kalhoro DH, Kalhoro MS, Rahu BA, Sahito RGA, Yin Y, Yang H, Chughtai MI, Tan B. The Role of Oxidative Stress and Antioxidant Balance in Pregnancy. Mediators Inflamm. 2021 Sep 27;2021:9962860. doi: 10.1155/2021/9962860. eCollection 2021.
PubMed 34616234de Andrade Ramos BR, Witkin SS. The influence of oxidative stress and autophagy cross regulation on pregnancy outcome. Cell Stress Chaperones. 2016 Sep;21(5):755-62. doi: 10.1007/s12192-016-0715-3. Epub 2016 Jul 6.
PubMed 27383757Aleksandrova K, Koelman L, Rodrigues CE. Dietary patterns and biomarkers of oxidative stress and inflammation: A systematic review of observational and intervention studies. Redox Biol. 2021 Jun;42:101869. doi: 10.1016/j.redox.2021.101869. Epub 2021 Jan 22.
PubMed 33541846
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal, Randomized, Parallel-Group, Controlled Clinical Study to Evaluate the Effectiveness of a Nutritional Education Intervention in Uncomplicated Pregnancy
- ClinicalTrials.gov ID
- NCT07550309
- Acronym / sponsor ID
- MaNu / MaNu
- Conditions
- Pregnancy, Uncomplicated Pregnancy, Diet, Food and Nutrition, Weight Gain During Pregnancy, Oxidative Stress, Nutrition Therapy
- Keywords
- Nutritional education in pregnancy, Group-based dietary intervention, Gestational weight gain, Uncomplicated pregnancy, Randomized controlled trial, Prenatal nutrition counseling, Maternal diet intervention, Dietary behavior change in pregnancy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale CN2 Alba-BraUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether a structured nutritional education intervention can improve gestational weight gain outcomes and related maternal and neonatal health indicators in women with uncomplicated pregnancy. The main question it aims to answer is whether a group-based nutritional education program increases the proportion of women achieving gestational weight gain within Institute of Medicine (IOM) recommended ranges compared with standard prenatal care.
Researchers will compare a structured nutritional education intervention group to a control group receiving routine prenatal care and a nutritional information brochure to see if the intervention improves gestational weight gain within recommended ranges and affects maternal and neonatal outcomes.
Participants in the intervention group will:
- Attend three weekly group-based nutritional education sessions delivered by trained healthcare professionals
- Attend one practical cooking (show-cooking) session
Participants in the control group will:
- Receive routine prenatal care and a written nutritional information brochure
- Be followed from early pregnancy until 8 weeks postpartum
All participants (including control group) will:
- Record body weight regularly throughout pregnancy using a telemedicine system
- Complete questionnaires on dietary intake and quality of life at multiple time points
- Undergo assessments of body composition and urinary biomarkers of oxidative stress during pregnancy
Detailed description
This study is based on the hypothesis that dietary behavior during pregnancy plays a key role in determining maternal metabolic adaptation and pregnancy outcomes, particularly through its influence on gestational weight gain regulation and oxidative stress balance.
Pregnancy is characterized by physiological metabolic and endocrine adaptations that increase susceptibility to both under- and over-nutrition. Inadequate dietary patterns may contribute to excessive gestational weight gain, which has been associated with increased risk of maternal and neonatal complications. Conversely, nutritional imbalance may also affect fetal development and long-term health trajectories. Despite existing recommendations for healthy eating during pregnancy, adherence in real-world settings remains suboptimal, suggesting the need for structured behavioral interventions.
In addition to metabolic effects, pregnancy is associated with a physiological increase in oxidative stress, which is involved in placental development and fetal growth regulation. However, excessive oxidative stress has been linked to adverse outcomes including impaired placental function and increased risk of metabolic and hypertensive disorders. Dietary patterns rich in antioxidants, such as those emphasizing high-quality nutrients and balanced macronutrient intake, may contribute to modulating oxidative stress pathways.
The intervention tested in this study is grounded in behavioral nutrition and health education principles, with the aim of improving dietary awareness, food selection skills, and long-term adherence to nutritional recommendations. The group-based format is designed to enhance engagement, facilitate peer interaction, and improve cost-effectiveness compared to individual counseling approaches.
The study employs a randomized controlled design to minimize selection bias and allow causal inference regarding the effect of the intervention. Stratified randomization is used to ensure balance across clinically relevant prognostic factors, including pre-pregnancy BMI and parity, which are known to influence gestational weight gain and pregnancy outcomes.
The longitudinal structure of the study allows evaluation of both short-term behavioral changes during pregnancy and medium-term maternal outcomes extending into the postpartum period. The integration of behavioral, anthropometric, and biochemical assessments enables a multidimensional evaluation of the intervention's impact.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to either a structured nutritional education intervention group or a control group receiving routine prenatal care with provision of a nutritional information brochure. The study uses a parallel-group design, with each participant assigned to a single study arm and followed longitudinally throughout pregnancy and up to 8 weeks postpartum. Randomization is stratified according to pre-pregnancy body mass index (BMI) categories and parity, using permuted blocks to ensure balance between groups.
| Arm | Type | Receives |
|---|---|---|
| Structured Nutritional Education Intervention | Experimental | Behavioral: Structured Nutritional Education ProgramParticipants receive a structured group-based nutritional education program delivered during pregnancy by trained healthcare professionals. The intervention includes group educational sessions focused on healthy dietary patterns during pregnancy, nutrient requirements, meal planning, and gestational weight management, plus one practical cooking (show-cooking) session. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the control arm. |
| Routine Care + Brochure | Active comparator | Other: Routine Prenatal Care With Nutritional Information BrochureParticipants receive routine prenatal care according to standard clinical practice. In addition, they are provided with a written nutritional information brochure containing general dietary recommendations for pregnancy. This arm serves as the control condition for comparison with the structured nutritional education intervention. Participants are followed longitudinally through pregnancy and postpartum and complete the same study assessments as the intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women with gestational age ≤ 17 weeks at enrollment
- Age ≥ 18 years
- Ability to provide written informed consent
- Availability of a personal smartphone for study participation and data reporting
- Availability of a personal weight scale for home monitoring
Key exclusion criteria (11 listed)
- Multiple pregnancy
- Pre-existing hypertension
- Pre-existing diabetes mellitus
- Pre-pregnancy body mass index (BMI) < 18.5 kg/m²
- Pre-pregnancy body mass index (BMI) ≥ 35 kg/m²
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured Nutritional Education ProgramParticipants receive a structured group-based nutritional education program delivered during pregnancy by trained healthcare professionals. The program includes three weekly group educational sessions and one practical cooking (show-cooking) session. The intervention focuses on improving knowledge and practical skills related to healthy dietary patterns during pregnancy, nutrient intake, and gestational weight management. | Behavioural | Structured Nutritional Education Intervention |
| Routine Prenatal Care With Nutritional Information BrochureParticipants receive routine prenatal care according to standard clinical practice. In addition, they are provided with a written nutritional information brochure containing general dietary recommendations for pregnancy. No structured educational sessions or group-based interventions are delivered in this arm. | Other | Routine Care + Brochure |
Primary outcome
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges
Time frame: From enrollment (12-17 weeks of gestation) to delivery.
This outcome assesses the proportion of participants whose total gestational weight gain falls within the Institute of Medicine (IOM) recommended ranges according to pre-pregnancy body mass index (BMI) categories. Pre-pregnancy BMI is used to classify recommended weight gain ranges, and total gestational weight gain is evaluated at the end of pregnancy.
8 secondary outcomes
Change in Urinary Oxidative Stress Biomarkers During Pregnancy
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Dietary Intake During Pregnancy
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Maternal Quality of Life During Pregnancy
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Change in Maternal Body Composition During Pregnancy
Time frame: From enrollment (12-17 weeks of gestation) to 30-35 weeks of gestation.
Gestational Weight Gain Rate Within Institute of Medicine Recommendations
Time frame: From enrollment (12-17 weeks of gestation) to delivery.
Incidence of Maternal Pregnancy Complications
Time frame: From enrollment (12-17 weeks of gestation) to delivery.
Incidence of Neonatal Complications
Time frame: At delivery.
Postpartum Maternal Weight Change
Time frame: From delivery to 8 weeks postpartum.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Results publication: PubMed 34055070Simon-Szabo Z, Fogarasi E, Nemes-Nagy E, Denes L, Croitoru M, Szabo B. Oxidative stress and peripartum outcomes (Review). Exp Ther Med. 2021 Jul;22(1):771. doi: 10.3892/etm.2021.10203. Epub 2021 May 17.
- Results publication: PubMed 34579011Santander Ballestin S, Gimenez Campos MI, Ballestin Ballestin J, Luesma Bartolome MJ. Is Supplementation with Micronutrients Still Necessary during Pregnancy? A Review. Nutrients. 2021 Sep 8;13(9):3134. doi: 10.3390/nu13093134.
- Results publication: PubMed 34968458Marshall NE, Abrams B, Barbour LA, Catalano P, Christian P, Friedman JE, Hay WW Jr, Hernandez TL, Krebs NF, Oken E, Purnell JQ, Roberts JM, Soltani H, Wallace J, Thornburg KL. The importance of nutrition in pregnancy and lactation: lifelong consequences. Am J Obstet Gynecol. 2022 May;226(5):607-632. doi: 10.1016/j.ajog.2021.12.035. Epub 2021 Dec 27.
- Results publication: PubMed 34616234Hussain T, Murtaza G, Metwally E, Kalhoro DH, Kalhoro MS, Rahu BA, Sahito RGA, Yin Y, Yang H, Chughtai MI, Tan B. The Role of Oxidative Stress and Antioxidant Balance in Pregnancy. Mediators Inflamm. 2021 Sep 27;2021:9962860. doi: 10.1155/2021/9962860. eCollection 2021.
- Results publication: PubMed 27383757de Andrade Ramos BR, Witkin SS. The influence of oxidative stress and autophagy cross regulation on pregnancy outcome. Cell Stress Chaperones. 2016 Sep;21(5):755-62. doi: 10.1007/s12192-016-0715-3. Epub 2016 Jul 6.
- Results publication: PubMed 33541846Aleksandrova K, Koelman L, Rodrigues CE. Dietary patterns and biomarkers of oxidative stress and inflammation: A systematic review of observational and intervention studies. Redox Biol. 2021 Jun;42:101869. doi: 10.1016/j.redox.2021.101869. Epub 2021 Jan 22.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cloè Dalla Costa principal investigator
SC Nutrizione Clinica e Disturbi del Comportamento Alimentare, Ospedale Michele e Pietro Ferrero, ASL CN2, Verduno (CN), Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Nutritional Education Program and Routine Prenatal Care With Nutritional Information Brochure in people with Pregnancy and Uncomplicated Pregnancy, run by Azienda Sanitaria Locale CN2 Alba-Bra at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants Achieving Gestational Weight Gain Within Institute of Medicine (IOM) Recommended Ranges (time frame: From enrollment (12-17 weeks of gestation) to delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07550309, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.