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MOTHER trial: Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding


- candidate number15492
- NTR NumberNTR4197
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-okt-2013
- Secondary IDsNL41011.018.12 METC nummer
- Public TitleMOTHER trial: Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding
- Scientific TitleMaternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding
- ACRONYMMOTHER
- hypothesisWe hypothesize that enteral tube feeding is a more effective treatment for HG symptoms than intravenous rehydration and improves pregnancy outcome.
- Healt Condition(s) or Problem(s) studiedVomiting, Pregnancy, Tube feeding, Intravenous rehydration, Neonatal and maternal effects, Long term results, Quality of life
- Inclusion criteriaGestational age between 5+0 and 19+6 weeks
Informed consent
Women with singleton or multiple pregnancy
Hospital admission because of hyperemesis gravidarum
First admission or readmission for HG
- Exclusion criteriaMaternal age <18 years
Mola hydatidosa pregnancy
Non-vital pregnancy
Acute infection causing vomiting (acute appendicitis, pyelonephritis)
Contra-indication for enteral tube feeding (including oesophageal varices, allergies to compounds in enteral tube mix)
HIV infection
Insufficient command of Dutch or English language
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-aug-2013
- planned closingdate1-dec-2016
- Target number of participants120
- InterventionsEarly enteral tube feeding, continued until sufficient oral intake versus intravenous rehydration (care as usual) in patients admitted because of hyper,emesis gravidarum.
- Primary outcomeThe primary maternal outcome is the Pregnancy Unique Quantification of Emesis and nausea (PUQE) score one week after randomization.
The primary neonatal outcome is birth weight.
- Secondary outcomeSecondary outcomes will be maternal quality of life, duration of hospital stay and admission rates, maternal weight, ketonuria, neonatal morbidity, small for gestational age (SGA), prematurity, costs and molecular outcomes in umbilical cord blood and placental tissue that relate to HG.
- TimepointsQuality fo life will be measured at baseline with the following questionnaires: Nausea and Vomiting of Pregnancy QoL (NVPQoL), Hyperemesis Impact of Symptoms (HIS), Hospital Anxiety and Depression Scale (HADS), Symptoms Check List-90 (SCL-90), Short Form-36 (SF-36), European Quality of Life (EQ5D).
Patients fill in additional NVPQoL, HIS and HADS questionnaires 1 and 3 weeks after randomization.
Patients will record the PUQE (which consists of 3 questions), dietary intake and weight at weekly intervals until 20 weeks of gestation. If dietary intake has normalized from 15 weeks gestation onwards, this will no longer be recorded.
In addition they will complete questionnaires 6 weeks after delivery (SF-36, HADS, EQ5D) and 12 months after delivery (SF-36, HADS, EQ5D, SCL-90).
- Trial web sitewww.studies-obsgyn.nl/mother
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. B.W.J. Mol
- CONTACT for SCIENTIFIC QUERIESProf. B.W.J. Mol
- Sponsor/Initiator Initiator
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryRationale: Hyperemesis gravidarum (HG), or intractable vomiting during pregnancy, is the single most frequent cause of hospital admission in early pregnancy. HG has a major impact on maternal quality of life and has repeatedly been associated with poor pregnancy outcome such as low birth weight. Currently, women with HG are admitted to hospital for intravenous fluid replacement, without receiving specific nutritional attention. Nasogastric tube feeding is sometimes used as last resort treatment . At present no randomised trials on dietary or rehydration interventions have been performed. Small observational studies indicate that enteral tube feeding effectively may have the ability to treat dehydration and malnutrition and alleviate nausea and vomiting symptoms

Objective: We aim to evaluate the effectiveness of early enteral tube feeding in addition to standard care on nausea and vomiting symptoms and pregnancy outcomes in HG patients

Study design: The MOTHER trial is a multicentre open label randomised controlled trial (www.studies- obsgyn.nl/mother)

Study population: Women ≥ 18 years and hospitalised for HG between 5+0 and 19+6 weeks gestation are eligible for participation

Intervention: Participants will be randomly allocated to standard care with intravenous rehydration or early enteral tube feeding in addition to standard care

Main study parameters: The primary outcome will be neonatal birth weight. Secondary outcomes will be the 24-hour Pregnancy Unique Quantification of Emesis and nausea score (PUQE-24), maternal weight gain, dietary intake, duration of hospital stay, number of readmissions, quality of life and side-effects. Also gestational age at birth, placental weight, umbilical cord plasma lipid concentration and neonatal morbidity will be evaluated. Analysis will be according to the intention to treat principle
- Main changes (audit trail)25-aug-2015: CHANGES:

Exclusion new:
Maternal age <18 years
Mola hydatidosa pregnancy
Non-vital pregnancy
Acute infection causing vomiting (acute appendicitis, pyelonephritis)
Contra-indication for enteral tube feeding (including oesophageal varices, allergies to compounds in enteral tube mix)
HIV infection

Intervention new:
Early enteral tube feeding, continued until sufficient oral intake versus intravenous rehydration (care as usual) in patients admitted because of hyperemesis gravidarum

Primary outcome new:
The primary outcome is neonatal birth weight

Secondary outcome new:
Secondary outcomes are Pregnancy Unique Quantification of Emesis and nausea score (PUQE-24) one week after randomization, maternal quality of life, duration of hospital stay and admission rates, maternal weight, ketonuria, neonatal morbidity, small for gestational age (SGA), prematurity and molecular outcomes in umbilical cord blood and placental tissue that relate to HG.

Timepoints:
Quality of life will be measured at baseline using the following questionnaires: Nausea and Vomiting of Pregnancy QoL (NVPQoL), Hyperemesis Impact of Symptoms (HIS), Hospital Anxiety and Depression Scale (HADS), Symptoms Check List-90 (SCL-90), Short Form-36 (SF-36), European Quality of Life (EQ5D). Patients fill out additional NVPQoL, HIS and HADS questionnaires 1 and 3 weeks after randomization. Patients will record the PUQE-24, dietary intake and weight at weekly intervals until 20 weeks gestation. If dietary intake has normalized from 15 weeks gestation onwards, this will no longer be recorded. In addition they will complete questionnaires 6 weeks after delivery (SF-36, HADS, EQ5D) and 12 months after delivery (SF-36, HADS, EQ5D, SCL-90)
- RECORD2-okt-2013 - 25-aug-2015


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