Please select the eligibility criteria that correspond to the clinical trial below.
Title: Misoprostol in the Treatment of Post Partum Hemorrhage: A Placebo Randomised Controlled Trial in 4 Karachi Hospitals
Brief Summary: Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.


Options:
A: Inclusion Criteria:

* Women who have given birth to 1 or more live-born infants (para 1 or more)
* Vaginal delivery

Exclusion Criteria:

* Refusal or inability to give informed consent
* Delivery regarded as abortion according to local gestational age limits
* Inability to take misoprostol sublingually
* Cesarean section
* Assisted vaginal delivery
B: Inclusion Criteria:

* Gestational age equal to or greater than 28 weeks pregnant
* Planning to deliver at home or at a sub-center in the Belgaum District, Karnataka India
* Anticipating a spontaneous vaginal delivery
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Previous caesarian section
* Scheduled for caesarian section
* Hemoglobin level less than 8 Gms%
* Episodes of antepartum bleeding during the current pregnancy
* Blood pressure more than 140 mm of Hg systolic and 90 mm of Hg diastolic
* In active labor and not previously screened, recruited, and consented
* Absence of fetal heart sounds
* Multiple pregnancy
* Known history of bronchial asthma
* Prior enrollment in this study during a previous pregnancy
* History of complications (ante/postpartum hemorrhage/retained placenta/ acute inversion of uterus) during a previous pregnancy
* High risk conditions including: diabetes, cardiac ailments, seizures, placenta previa or anticipated breech delivery.
* Receiving injectable medicine at time of delivery
C: Inclusion Criteria:

* Vaginal delivery
* Postpartum hemorrhage due to suspected uterine atony
* Depending on study group: administration of prophylactic uterotonics in third stage of labor

Exclusion Criteria:

* Known allergy to misoprostol or other prostaglandin
* C-section for current delivery
D: Inclusion Criteria:

* All women delivering vaginally with clinically diagnosed PPH requiring uterotonics

Exclusion Criteria:

* Refusal to give consent for participation or if the woman is too distressed to give consent
* Woman is not entitled to give informed consent (e.g. minors without a guardian)
* Woman who had a caesarean section
* Delivery is regarded as abortion (gestational age \< 28 weeks)

Answer: D