PregnancyPhase 4NCT00635947
Study of Maternal Hydration on the Increase of Amniotic Fluid Index
A Phase 4 study testing isotonic solution and water in people with Pregnancy, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
Trial summary
The purpose of this study is to determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- isotonic solution and water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 1998to Jan 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- gestational age between 33 and 36 weeks
- singleton pregnancy
- intact membranes
- initial AF index between 5 and 95 per cent
Who cannot join
- no maternal complications
- no fetal structural malformation
- no evidence of fetal distress on nonstress test
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Medicine of Botucatu--São Paulo State University (Unesp)--
Botucatu, São Paulo, 18600
About this study
Official title: Randomized Trial of Maternal Hydration on the Increase of Amniotic Fluid Index
The purpose of this study is to determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.
Read the detailed description
Objective: To determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.
Subjects and Methods: Women with normal AF index and gestational age between the 33 and 36 weeks without maternal complications were randomized into three groups (isotonic solution, water, control). The isotonic solution and water groups were instructed to drink 1.5L of respective solution; the control group was instructed to drink 200mL of water. AF index was measured before and after hydration. The investigator performing the AF index was blinded to the subject's group.
Results: Ninety-nine women completed the study without any maternal adverse effects. The mean increase in amniotic fluid index after hydration was significantly greater in the isotonic solution and water groups (12.1mm, p=0.02; 13.1mm, p=0.05; respectively) than the control group (1.4mm, p=0.74). There was no significant difference between the isotonic solution and water groups. Hydration with isotonic solution and water improved the chance of 20% of increase of amniotic fluid index in 10.2 (95% CI 1.9-98.9) and 6.0 (95% CI 1.0-45.5) times respectively.
Conclusion: Maternal hydration with isotonic solution or water increased AF index in women with normohydramnios.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isotonic solutionOther
Also called Isotonic
1.5 L- during 2-4hours
waterOther
Also called Water 1.5
1.5 L- during 2-4hours
waterOther
Also called Water 200
200mL- during 2-4hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | isotonic solution - 1.5L Receives: Other: isotonic solution |
| 2 | Active comparator | water- 1.5L Receives: Other: water |
| 3 | Placebo comparator | water-200mL Receives: Other: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
Measured: 4horas
Secondary outcomes (1)
compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
Measured: 4horas
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2008 (estimated)
- Study startJul 1998
- Primary completionJul 1999
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPECLIN HC FM Botucatu Unesp
- Sponsor type
- University, hospital or other
- Investigators
- Vera M Borges, PhD, Principal investigator, School of Medicine of Botucatu--São Paulo State University (Unesp)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635947
- Sponsor's protocol ID
- upeclin/HC/FMB-Unesp-08
- Status last verified
- Mar 2008
- First submitted
- 7 Mar 2008
- Last updated
- 14 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kilpatrick SJ, Safford KL, Pomeroy T, Hoedt L, Scheerer L, Laros RK. Maternal hydration increases amniotic fluid index. Obstet Gynecol. 1991 Dec;78(6):1098-102.
PubMed 1945215Kilpatrick SJ, Safford KL. Maternal hydration increases amniotic fluid index in women with normal amniotic fluid. Obstet Gynecol. 1993 Jan;81(1):49-52.
PubMed 8416460
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Maternal Hydration on the Increase of Amniotic Fluid Index
- ClinicalTrials.gov ID
- NCT00635947
- Acronym / sponsor ID
- upeclin/HC/FMB-Unesp-08
- Conditions
- Pregnancy
- Keywords
- Amniotic fluid index, maternal hydration, isotonic solution, Amniotic Fluid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- UPECLIN HC FM Botucatu UnespUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- Jul 1999 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 14 Mar 2008 (estimated)
- 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 purpose of this study is to determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.
Detailed description
Objective: To determine the effect of maternal hydration with oral isotonic solution and water on amniotic fluid (AF) index in women with normohydramnios.
Subjects and Methods: Women with normal AF index and gestational age between the 33 and 36 weeks without maternal complications were randomized into three groups (isotonic solution, water, control). The isotonic solution and water groups were instructed to drink 1.5L of respective solution; the control group was instructed to drink 200mL of water. AF index was measured before and after hydration. The investigator performing the AF index was blinded to the subject's group.
Results: Ninety-nine women completed the study without any maternal adverse effects. The mean increase in amniotic fluid index after hydration was significantly greater in the isotonic solution and water groups (12.1mm, p=0.02; 13.1mm, p=0.05; respectively) than the control group (1.4mm, p=0.74). There was no significant difference between the isotonic solution and water groups. Hydration with isotonic solution and water improved the chance of 20% of increase of amniotic fluid index in 10.2 (95% CI 1.9-98.9) and 6.0 (95% CI 1.0-45.5) times respectively.
Conclusion: Maternal hydration with isotonic solution or water increased AF index in women with normohydramnios.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: isotonic solutionisotonic solution - 1.5L |
| 2 | Active comparator | Other: waterwater- 1.5L |
| 3 | Placebo comparator | Other: waterwater-200mL |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- gestational age between 33 and 36 weeks
- singleton pregnancy
- intact membranes
- initial AF index between 5 and 95 per cent
Key exclusion criteria (3 listed)
- no maternal complications
- no fetal structural malformation
- no evidence of fetal distress on nonstress test
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 |
|---|---|---|
| isotonic solutionAlso: Isotonic1.5 L- during 2-4hours | Other | 1 |
| waterAlso: Water 1.51.5 L- during 2-4hours | Other | 2 |
| waterAlso: Water 200200mL- during 2-4hours | Other | 3 |
Primary outcome
the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
Time frame: 4horas
1 secondary outcome
compare the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios
Time frame: 4horas
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2008.
- Results publication: PubMed 1945215Kilpatrick SJ, Safford KL, Pomeroy T, Hoedt L, Scheerer L, Laros RK. Maternal hydration increases amniotic fluid index. Obstet Gynecol. 1991 Dec;78(6):1098-102.
- Results publication: PubMed 8416460Kilpatrick SJ, Safford KL. Maternal hydration increases amniotic fluid index in women with normal amniotic fluid. Obstet Gynecol. 1993 Jan;81(1):49-52.
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Vera M Borges, PhD principal investigator
School of Medicine of Botucatu--São Paulo State University (Unesp)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing isotonic solution and water in people with Pregnancy, run by UPECLIN HC FM Botucatu Unesp at 1 site in Brazil.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 14 Mar 2008. 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 Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the effects of maternal oral hydration with isotonic fluid and water on amniotic fluid index in women with normohydramnios (time frame: 4horas). 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 NCT00635947, which also lists 2 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 14 Mar 2008.