Notice: You are viewing an unstyled version of this page. Are you using a very old browser? If so, please consider upgrading

MaatHRI: Safety of induction and augmentation of labour in pregnant women with anaemia - Privacy notice

This Privacy Notice is being provided in compliance with the General Data Protection Regulation (GDPR) 2018. The following questions and answers give more detail about how information collected about participants as part of the 'MaatHRI: Safety of induction and augmentation of labour in pregnant women with anaemia' study is handled and processed.

What is the study?

At present, we do not know whether stimulating labour and delivery is safe for pregnant women with anaemia, particularly regarding the risk of bleeding during and after childbirth. Anaemia is a condition in which the body has lower than the normal number of red blood cells or the red blood cells do not contain enough haemoglobin (a protein that gives red colour to the blood). Further, we do not know if the amount of specific components in blood that stops or controls bleeding (clotting factors) in pregnant women with anaemia is similar to that of pregnant women without anaemia.

This is a study of 10,800 pregnant women with anaemia in the third trimester of pregnancy planning to undergo a vaginal delivery to investigate the risk of increased blood loss at childbirth associated with stimulating labour and delivery. The study is being undertaken through the Maternal and perinatal Health Research collaboration, India (MaatHRI) which is a network of 14 hospitals across four states in India.

What information are collected from participants taking part in the study?

If a pregnant woman decides to take part, the study nurses in the hospital will record information in a form by asking her questions and also collect information from hospital records and investigation reports. This will be done at two time-points:

During the current antenatal visit: A nurse will collect information about the woman including name, contact details and date of birth. She will be asked to provide information about her previous and current pregnancies and any known medical problems. The nurse will collect information from the reports of blood and urine tests and other investigations that were done during this pregnancy as part of her routine antenatal care. The nurse will also collect blood samples for conducting some tests.

During labour and delivery: A nurse will measure the amount of blood the woman may lose after childbirth by using a blood collection drape. The drape consists of a plastic collecting pouch connected to a plastic sheet which will be placed under her buttocks by the nurse during labour. Belts (made of plastic) will be tied loosely around her abdomen. The study nurse will also collect information about the childbirth process, and clinical details about the woman's and her baby's health from the hospital records.

What is the purpose of collecting and processing the information?

The purpose is to understand whether women with anaemia who undergo stimulation in labour and delivery are more at risk of bleeding than women with anaemia who do not undergo stimulation. In addition, we will compare the amount of the different clotting factors in the blood of pregnant women who have anaemia and those who do not have anaemia. The results will be used to develop guidance on the safety of stimulating labour and delivery in pregnant women with anaemia, and to develop ways to control excessive bleeding during or after delivery in pregnant women with anaemia.

On what basis will personal information be processed?

The University of Oxford is using personal information from the participants for research purposes and will only process personal information as necessary to undertake research that is being carried out in the public interest. This is known under data protection law as our “legal basis”. The legal basis for the processing and storage of participants' personal information for 'MaatHRI: Safety of induction and augmentation of labour in pregnant women with anaemia' study and its sub-studies is that it is 'a task in the public interest' (Article 6 (1) (e) EU General Data Protection Regulation (GDPR)). A required condition under GDPR to process participants' special category (sensitive) personal information is met as it is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes (Article 9 (2) (j) GDPR). In addition, 'legitimate interest' (Article 6(1)f) is also our legal basis for processing and sharing information.

Is the information collected and stored using secure means?

If a woman agrees to take part in the study, some personal information such as her name and contact details will be collected and securely stored in an internet platform (cloud-based server) hosted in India.

We will take all measures to ensure strict confidentiality of the data including concealing information using codes (or encryption), separating concealed personal information from the research data, and protecting computer files with passwords.

It will not be possible to identify any participant from any publications of the results relating to the study.

Authorised members of the University of Oxford and the collaborating obstetricians in each hospital may be given access to data for monitoring and/or audit of the study to ensure that the research is complying with applicable regulations.

Participants' personal information will not be made public, nor will be shared with any third party in the absence of appropriate confidentiality obligations.

Any sharing of the data with third parties is described in further detail below.

Sharing data

Will we provide participants' personal information to others?

We may share research data with companies or organisations carrying out related research. Participants' name and other information which could directly identify them will always be removed from research data shared in this way; however, the research data shared may contain some personal information that could indirectly identify participants. Our basis for this sharing of research data is our legitimate interest in obtaining support from these third parties that enables us to carry out our own research, such as this study. The third party recipients of the data will use it for their own legitimate interests, namely research and development activities in the field of pregnancy care. We will in any event make sure that as much information that could identify the participants is removed from any data we share with third parties whenever possible and that any data transfer is done securely. We also require all third parties to treat this information in accordance with the law.

We may disclose participants' personal information to our insurers and/or professional advisers as necessary for the purposes of obtaining and maintaining insurance coverage, managing risks, obtaining professional advice and managing legal disputes.

We may disclose personal information to our suppliers or subcontractors in connection with the uses described above (e.g. organisations which host the servers on which our data is stored and email service providers). We do not allow our third-party service providers to use participants' personal information for their own purposes and only permit them to process personal information for specified purposes and in accordance with our instructions.

We may also disclose participants' personal information where such disclosure is necessary for compliance with a legal obligation to which we are subject, or in order to protect participants' vital interests or the vital interests of another person.

Will there be international transfer of participants' personal information outside India?

Some of the third parties to whom we may transfer participants' personal information, discussed above, may be located outside of India or may transfer personal information to their own service providers located outside India. If so, we will ensure that transfers will only be made with appropriate safeguards, such as the use of standard data protection clauses adopted or approved by the European Commission/ UK Government. Participants will be advised to contact us to enquire about such safeguards so that they may obtain a copy of them or so that we may direct the participants to them.

For how long will the personal information be held by the MaatHRI study team?

We will only retain participants' personal information for as long as reasonably necessary to fulfil the purposes we collected it for, including for the purposes of the study and any further research as outlined above, as well as for the purpose of satisfying any legal or reporting requirements.

We will delete information which can directly identify participants, such as her name, date of birth, and address from our records 18 months after the end of the study.

What are the rights of participants with respect to their personal information?

Data protection regulation provides study participants with control over their personal information and how it is used. When a woman agrees to her information being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate.

Further information about participants' rights with respect to personal information under the General Data Protection Regulation is available on the University of Oxford's Compliance webpage. If anyone would like to contact us directly for more information about how we process and protect data collected for research, please email the Chief Investigator of MaatHRI: or you can phone on +44 (0) 1865 617820 or write to: MaatHRI, National Perinatal Epidemiology Unit, NDPH, University of Oxford, Richard Doll Building, Old Road Campus, OX3 7LF.


If a participant wants to exercise any of the rights described above or are dissatisfied with the way we have used their personal information, they are advised to contact the University's Information Compliance Team at or by telephone on +44 (0) 1865 270285, who will investigate the matter. The same email address may be used to contact the University's Data Protection Officer. If she remains dissatisfied, she has the right to lodge a complaint with the ICO at or call their helpline on 0303 123 1113.

The University's legal name is The Chancellor, Masters and Scholars of the University of Oxford.

Participation in the study

Participation in this study is entirely voluntary.

What if a participant wants to withdraw from the study?

Participants can also withdraw if they later change their mind, without giving a reason and this will not affect the clinical care they receive. If a participant decides to withdraw from the study at a later point, we will stop processing her personal information as soon as we can. Please note that if a participant withdraws this will not invalidate any processing of the information before she decided to withdraw, and we may continue to use the data collected up to that point going forward, in compliance with the law.

Who is responsible for the data?

The University of Oxford, as sponsor, is the data controller. This means that we, as University of Oxford researchers, are responsible for looking after the information collected from participants and using it properly.

What happens at the end of the study?

Participants will continue to receive their routine care as required by their clinical care team.

The study results (in which participants will not be identified) will be published in scientific journals and as reports; presented at conferences; used to develop further research applications and clinical guidance; and provided to all participants as a summary and a link will be added to the 'MaatHRI' website from which participants could get the information. Participants can also contact us to ask about the study findings.

We assure the participants that they will not be identified from any report or publication placed in the public domain.

Some of the research being undertaken may also contribute to the fulfilment of an educational requirement (e.g. a masters or a doctoral thesis).

Updated: Tuesday, 01 June 2021 09:24 (v4)

Contact us

For more information about MaatHRI, please view the contact details page